K252126 is an FDA 510(k) clearance for the MitraPatch Mitral Valve Repair System. This device is classified as a Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement (Class II - Special Controls, product code PAW).
Submitted by Chawla Heart Technologies, LLC (Bloomfield, US). The FDA issued a Cleared decision on December 4, 2025, 150 days after receiving the submission on July 7, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470. To Repair Or Replace Chordae Tendinae..
| 510(k) Number | K252126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2025 |
| Decision Date | December 04, 2025 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PAW - Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |
| Definition | To Repair Or Replace Chordae Tendinae. |