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FDA 510(k)

MitraPatch Mitral Valve Repair System

K-Number: K252126 · 2025-12-04

ApplicantChawla Heart Technologies, LLC
Decision Date2025-12-04
Product CodePAW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Chawla Heart Technologies, LLC. The 510(k) number is K252126.

When was MitraPatch Mitral Valve Repair System approved by the FDA?

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

What company makes MitraPatch Mitral Valve Repair System?

MitraPatch Mitral Valve Repair System is manufactured by Chawla Heart Technologies, LLC.

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

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

Related Clinical Trials

NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT04818502 Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation ACTIVE_NOT_RECRUITING NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT04147884 A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41114311 From bench to bedside and back: translational cardiovascular interventions in veterinary medicine. Postepy w kardiologii interwencyjnej = Advances in interventional cardiology (2025)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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