DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent— 510(k) K261792

Name: FDA 510(k) clearance K261792
Creator: U.S. Food and Drug Administration
Published: 2026-10-23

Substantially Equivalent

Medtronic

FDA 510(k) clearance K261792 for DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent, Substantially Equivalent on 2026-10-23. Applicant: Medtronic.

Clearance details

Applicant: Medtronic
Advisory panel: Unknown
Date received: 2026-05-29
Decision date: 2026-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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