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MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. vs Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation: FDAPulse comparison

MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.'s review days of 276 is 1.0x Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation's 269 (95th percentile). MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. is dated 2026-10-05; Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation 2026-10-16.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. compare to Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation?

FieldMyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation
Record510(k) clearance510(k) clearance
510(k) numberK260005K260168
DeviceMyoVista wavECG (DG-200-B15-003)Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)
ApplicantHeartSciences, Inc.Skycade Med Corporation
Specialty / panelCardiovascularCardiovascular
Product codeDPSDQX
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-01-022026-01-20
Decision date2026-10-052026-10-16
Review time (days)276269
Third-party reviewNoNo
Applicant locationSouthlake, TX, USDallas, TX, US
amount percentile95th93rd
Predicate Speed & CAPA Advisory Opportunity Score61/10061/100
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Official records: MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. · Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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