FDA 510(k)

MitraPatch Mitral Valve Repair System

Numéro K : K252126 · 2025-12-04

Date de décision2025-12-04

Code produitPAW

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

MitraPatch Mitral Valve Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Chawla Heart Technologies, LLC. It received FDA 510(k) clearance on 2025-12-04 under 510(k) number K252126. The device is classified under product code PAW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the MitraPatch Mitral Valve Repair System?

MitraPatch Mitral Valve Repair System is a medical device that received FDA 510(k) clearance on 2025-12-04. The listed applicant is Chawla Heart Technologies, LLC. The 510(k) number is K252126.

When did MitraPatch Mitral Valve Repair System receive FDA 510(k) clearance?

MitraPatch Mitral Valve Repair System received FDA 510(k) clearance on 2025-12-04, under 510(k) number K252126.

Who is the listed applicant for MitraPatch Mitral Valve Repair System?

The FDA 510(k) record lists Chawla Heart Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MitraPatch Mitral Valve Repair System?

The FDA product code for MitraPatch Mitral Valve Repair System is PAW.

Essais cliniques associés

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Source officielle

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