510(k) K252126

Device: MitraPatch Mitral Valve Repair System
Applicant: Chawla Heart Technologies, LLC
510(k) number: K252126
Product code: PAW
Decision: Substantially Equivalent (SESE)
Decision date: 2025-12-04
Date received: 2025-07-07
Regulation: 870.3470
Classification name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K141060	CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT	On-X Life Technologies, Inc.	2014-06-06
K121173	CHORD-X EPTFE SUTURE	On-Xlifetechnologies	2012-08-16