MitraPatch Mitral Valve Repair System— 510(k) K252126

Name: FDA 510(k) clearance K252126
Creator: U.S. Food and Drug Administration
Published: 2025-12-04

Substantially Equivalent

Chawla Heart Technologies, LLC

FDA 510(k) clearance K252126 for MitraPatch Mitral Valve Repair System, Substantially Equivalent on 2025-12-04. Applicant: Chawla Heart Technologies, LLC. Device class: 2.

Clearance details

Applicant: Chawla Heart Technologies, LLC
Product code: Code PAW
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2025-07-07
Decision date: 2025-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomfield, CT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.