# DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792): 510(k) cleared for Medtronic

**Predicate Speed & CAPA Advisory Opportunity Score:** 42/100

| 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 |

## Why this score
- Fast 147-day review: this device is a strong predicate for similar products.
- Posted 13 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261792). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.