Cleared Traditional

K261792 - DLP PVC Left Heart Vent

Also marketed or referenced as:
DLP Malleable PVC Left Heart Vent DLP Silicone Left Heart Vent
K261792 · Medtronic · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
147d
Days
-
Risk

K261792 is an FDA 510(k) clearance for the DLP PVC Left Heart Vent.

Submitted by Medtronic (Mounds View, US). The FDA issued a Cleared decision on October 23, 2026 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K261792

510(k) Number K261792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2026
Decision Date October 23, 2026
Days to Decision 147 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 125d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -
K261792 · DLP PVC Left Heart Vent
Download PDF FDA Summary Medtronic