510(k) K252126 ยท PAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
MitraPatch Mitral Valve Repair System
| Applicant | Chawla Heart Technologies, LLC, Bloomfield CT, US |
| Decision | Substantially Equivalent, Dec 4, 2025 |
| Received | Jul 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252126
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.