510(k) K261792
K261792 is an FDA 510(k) premarket notification submitted by Medtronic for the device "DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent". The FDA issued a decision of Substantially Equivalent on Oct 23, 2026. Medtronic has 249 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 2026
- Date Received
- May 29, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No