# K252126: MitraPatch Mitral Valve Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Chawla Heart Technologies, LLC
- Decided: Dec 4, 2025 after 150 days
- Product code: PAW (Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953289 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141060: Chord-X Pre-Measured Loops for Mitral Chordal Replacement, On-X Life Technologies, Inc. (2014) Summary page 5.

## Indications for use
The MitraPatch is indicated to be used in the repair and replacement of marginal (primary) chordae tendinae only.

Source page: https://510kreport.com/device/K252126
Methodology: https://510kreport.com/methodology