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510(k) K252126

MitraPatch Mitral Valve Repair System by Chawla Heart Technologies, LLC — Product Code PAW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 4, 2025
Date Received: July 7, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Device Class: Class II
Regulation Number: 870.3470
Review Panel: CV
Submission Type

To repair or replace chordae tendinae.