DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792): 510(k) cleared for Medtronic
DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792): 510(k) cleared for Medtronic (Minnesota): 510(k) cleared for Medtronic. Its amount of 147 is above the median of 138 (55th percentile). Dated 12 days ago, it is in the active follow-up window. Score 42/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 147 · 55th percentile of 414 FDAPulse records · 1.1x the median
Free preview: all 12 published fields of this record are shown below. Locked: 11 related MN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261792 |
| Device | DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent |
| Applicant | Medtronic |
| Specialty / panel | Other |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-29 |
| Decision date | 2026-10-23 |
| Review time (days) | 147 |
| Third-party review | No |
| Applicant location | Mounds View, MN, US |
| amount percentile | 55th of 414 (median 138, 1.1x median) |
| Peer records CSV (12 MN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-23
- Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792): 510(k) cleared for Medtronic and 12 Minnesota peers
- Minnesota FDAPulse records like this one: 12
- DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792): 510(k) cleared for Medtronic's amount: 55th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Minnesota peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 147-day review: this device is a strong predicate for similar products.
- Posted 12 days ago.
What is the FDAPulse record for DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792): 510(k) cleared for Medtronic in Minnesota?
DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792) by Medtronic was cleared on 2026-10-23 after 147 days of review.
How does DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792): 510(k) cleared for Medtronic compare to other Minnesota FDAPulse records?
Its amount of 147 sits in the upper half (55th percentile) of 414 records; the median is 138. It is fresh: dated 12 days ago, inside the window where early outreach matters most.
DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792) | MN | 2026-10-23 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
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