- [Home](/) › - [FDAPulse](/v/fdapulse) › - [Hubs](/hub/fdapulse) › - Cardiovascular # FDA 510(k) clearances and recalls: Cardiovascular devices **52 FDA 510(k) clearances and recalls: Cardiovascular devices are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Kossel Medtech (Suzhou) Co., Ltd. with 2. Data last updated 2026-11-03; each record links to its official source and a full report.** Data as of 2026-11-03 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation Download all 52 FDA 510(k) clearances and recalls: Cardiovascular devices (CSV) — $4.99 → Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe [Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?panel=Cardiovascular) 52 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Kossel Medtech (Suzhou) Co., Ltd. (2). Each record links to a full report and the official source. Last updated 2026-11-03. Source: U.S. FDA openFDA. **Search, filter and export FDAPulse records** [Run instant live search with these filters](/v/fdapulse?panel=Cardiovascular&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdapulse/records.csv?panel=Cardiovascular) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## Get new FDAPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/fdapulse) Records 52 Most frequent - Kossel Medtech (Suzhou) Co., Ltd. (2) - Zylox Medtech Co., Ltd. (2) - Route 92 Medical, Inc. (2) - Sorin Group Italia S.R.L. (2) - Aventusoft, LLC (1) ## How do I get new FDA 510(k) clearances and recalls: Cardiovascular devices by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdapulse?panel=Cardiovascular) [Watch this exact filter](/v/fdapulse?panel=Cardiovascular#more-ways) [See alert plans](/v/fdapulse#pricing) ## What are the top FDA 510(k) clearances and recalls: Cardiovascular devices right now? | Record | Specialty | Type | Date | |---|---|---|---| | Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC | Cardiovascular | 510(k) | 2026-10-21 | | TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences | Cardiovascular | 510(k) | 2026-09-21 | | Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation | Cardiovascular | 510(k) | 2026-10-16 | | eClinics (K260075): 510(k) cleared for Ceiba Healthcare US, Inc. | Cardiovascular | 510(k) | 2026-10-07 | | MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. | Cardiovascular | 510(k) | 2026-10-05 | | OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp. | Cardiovascular | 510(k) | 2026-10-02 | | ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd. | Cardiovascular | 510(k) | 2026-09-30 | | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (K260250): 510(k) cleared for QT Medical, Inc. | Cardiovascular | 510(k) | 2026-09-29 | | DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies | Cardiovascular | 510(k) | 2026-09-25 | | S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp. | Cardiovascular | 510(k) | 2026-09-25 | | Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc. | Cardiovascular | 510(k) | 2026-09-25 | | Echo-2 (K254240): 510(k) cleared for Neko Health AB | Cardiovascular | 510(k) | 2026-09-22 | | Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd. | Cardiovascular | 510(k) | 2026-09-18 | | Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc. | Cardiovascular | 510(k) | 2026-09-18 | | Deterioration Index Version 2 (K260008): 510(k) cleared for Epic Systems Corporation | Cardiovascular | 510(k) | 2026-09-18 | | Aristotle 65 Macrowire (K254181): 510(k) cleared for Scientia Vascular | Included in the full CSV with every column 🔒 Unlock all 52 records → | | NC PTA Balloon Dilatation Catheter (K254212): 510(k) cleared for Kossel Medtech (Suzhou) Co., Ltd. | Included in the full CSV with every column 🔒 Unlock all 52 records → | | Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB | Included in the full CSV with every column 🔒 Unlock all 52 records → | Browse 35 more matching record reports - [Aristotle 65 Macrowire (K254181): 510(k) cleared for Scientia Vascular](/report/fdapulse/aristotle-65-macrowire-k254181-ut--k254181) - [NC PTA Balloon Dilatation Catheter (K254212): 510(k) cleared for Kossel Medtech (Suzhou) Co., Ltd.](/report/fdapulse/nc-pta-balloon-dilatation-catheter-k254212-cn--k254212) - [Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB](/report/fdapulse/extroducer-infusion-catheter-system-k254051-se--k254051) - [Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Reco](/report/fdapulse/wearable-ecg-recorder-ymheart-xy-12-wearable-ecg-recorder-cn--k254119) - [Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.](/report/fdapulse/kinetic-software-library-k260640-tx--k260640) - [Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter (K260686): 510(k) cleared for Zylox Medtech Co., Ltd.](/report/fdapulse/zylox-panflex-percutaneous-transluminal-angioplasty-scoring-cn--k260686) - [Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices](/report/fdapulse/sensinel-cardiopulmonary-management-cpm-system-k260801-ma--k260801) - [Radius VSM and Accessories (K260676): 510(k) cleared for Masimo Corporation](/report/fdapulse/radius-vsm-and-accessories-k260676-ca--k260676) - [Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14) (K260490): 510(k) cleared for Shenzhen Ninenovo Technology Limited](/report/fdapulse/ninenovo-blood-oxygen-ring-bormb-01-6-bormb-01-7-bormb-01-8-cn--k260490) - [Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206) (K260470): 510(k) cleared for Shenzhen Brav Electronic Technologies Co., Ltd.](/report/fdapulse/electronic-blood-pressure-monitor-bp-204c-bp-204a-bp-215-bp-cn--k260470) - [SmartRead(TM) Medical Device Identifier (4100) (DEN260007): 510(k) cleared for BridgeSource Medical Corporation](/report/fdapulse/smartread-tm-medical-device-identifier-4100-den260007-tx--den260007) - [ZYLOX Hippo PTA Balloon Dilatation Catheter (K260416): 510(k) cleared for Zylox Medtech Co., Ltd.](/report/fdapulse/zylox-hippo-pta-balloon-dilatation-catheter-k260416-cn--k260416) - [STAR Apollo™ Mapping System (K263380): 510(k) cleared for Rhythm AI, Ltd.](/report/fdapulse/star-apollo-mapping-system-k263380-gb--k263380) - [Toro 71 Aspiration Catheter; Toro Aspiration Tubing (K262021): 510(k) cleared for Toro Neurovascular, Inc.](/report/fdapulse/toro-71-aspiration-catheter-toro-aspiration-tubing-k262021-ca--k262021) - [Route 92 Medical Full Length 046 Access System (K260220): 510(k) cleared for Route 92 Medical, Inc.](/report/fdapulse/route-92-medical-full-length-046-access-system-k260220-ca--k260220) - [Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit (K261089): 510(k) cleared for Maduro Medical, Inc.](/report/fdapulse/radical-064-reperfusion-catheter-radical-076-reperfusion-ca--k261089) - [Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266): 510(k) cleared for Route 92 Medical, Inc.](/report/fdapulse/route-92-medical-full-length-046-reperfusion-system-and-ca--k263266) - [Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016): 510(k) cleared for Centerline Biomedical](/report/fdapulse/intra-operative-positioning-system-iops-and-iops-visionary-oh--k263016) - [Dual Stage Venous Cannulae (K263092): 510(k) cleared for Sorin Group Italia S.R.L.](/report/fdapulse/dual-stage-venous-cannulae-k263092-it--k263092) - [Reprocessed BRK Transseptal Needle (K262917): 510(k) cleared for Innovative Health, LLC](/report/fdapulse/reprocessed-brk-transseptal-needle-k262917-az--k262917) - [Giranel Guiding Sheath Set (K262674): 510(k) cleared for Kossel Medtech (Suzhou) Co., Ltd.](/report/fdapulse/giranel-guiding-sheath-set-k262674-cn--k262674) - [The Circadia CX00 System (CX00) (K262447): 510(k) cleared for Circadia Health, Inc.](/report/fdapulse/the-circadia-cx00-system-cx00-k262447-ca--k262447) - [INDIGO® Aspiration System (K262904): 510(k) cleared for Penumbra, Inc.](/report/fdapulse/indigo-aspiration-system-k262904-ca--k262904) - [Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) (K262068): 510(k) cleared for CathRx, Ltd.](/report/fdapulse/khelix-magnetic-sensor-electrophysiology-catheter-ss1-mag-au--k262068) - [Excelsior Reach Microcatheter (K261649): 510(k) cleared for Stryker Neurovascular](/report/fdapulse/excelsior-reach-microcatheter-k261649-ca--k261649) - [LOBO Vascular Occlusion System (K262798): 510(k) cleared for Okami Medical, Inc.](/report/fdapulse/lobo-vascular-occlusion-system-k262798-ca--k262798) - [MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike (K262043): 510(k) cleared for Bayer Medical Care, Inc.](/report/fdapulse/medrad-mrxperion-mr-injection-system-and-mr-injection-pa--k262043) - [APRO 88 Catheter (K261938): 510(k) cleared for Alembic, LLC](/report/fdapulse/apro-88-catheter-k261938-ca--k261938) - [Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character). (K261469): 510(k) cleared for Barco N.V.](/report/fdapulse/nexxis-2-nexxis-or-2-nms-2-mna-240-mna-4x0-where-x-may-be--k261469) - [Elucid FFR-IQ (B.1) (K262015): 510(k) cleared for Elucid Bioimaging, Inc.](/report/fdapulse/elucid-ffr-iq-b-1-k262015-ma--k262015) - [Tri Stage Venous Cannulae (K262052): 510(k) cleared for Sorin Group Italia S.R.L.](/report/fdapulse/tri-stage-venous-cannulae-k262052-it--k262052) - [CrossFAST Integrated Microcatheter Advanced Delivery System (K262817): 510(k) cleared for Vantis Vascular, Inc.](/report/fdapulse/crossfast-integrated-microcatheter-advanced-delivery-system-ca--k262817) - [EnSite™ X EP System (K261729): 510(k) cleared for Abbott Medical](/report/fdapulse/ensite-x-ep-system-k261729-mn--k261729) - [JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778): 510(k) cleared for OrbusNeich Medical (Shenzhen) Co., Ltd.](/report/fdapulse/jade-score-pta-scoring-balloon-dilatation-catheter-k261778-cn--k261778) - [HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438): 510(k) cleared for Eurosets S.R.L](/report/fdapulse/horizon-8af-integrated-oxy-module-8af-and-horizon-cvr-it--k261438) More records in this hub: [page 2](/hub/fdapulse/specialty/cardiovascular/page/2) [Browse all FDAPulse record reports](/hub/fdapulse/records) ## Which related categories and locations should I check? ### Browse by record type [510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls) ### Browse by specialty [Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Dental (32)](/hub/fdapulse/specialty/dental) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic) ### Browse by record type by specialty [Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances) ## Frequently asked questions ### How many FDA 510(k) clearances and recalls: Cardiovascular devices are listed? 52 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23. ### Can I get alerts for Cardiovascular? Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page. Source: U.S. FDA openFDA. Informational only. [RSS feed of new records](/feed/fdapulse.xml) ## Often used together - [NPIPulse](/v/npipulse) - [EPAPulse](/v/epapulse) - [Municipal Public Works Prime Contract Operating Permit Renewal Pulse](/v/pubworksregrenewpulse) - [TrialRecruitmentPageAudit](/trialrecruitmentpageaudit) - [SubdomainShadowPulse](/subdomainshadowpulse) - [MigrationSignalRadar](/migrationsignalradar) Or get the [Healthcare Vendor Bundle](/v/fdapulse#more-ways) for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.