MitraPatch Mitral Valve Repair System
FDA 510(k) clearance K252126 · decided 2025-12-04
Clearance details
- K-number
- K252126
- Device name
- MitraPatch Mitral Valve Repair System
- Applicant
- Chawla Heart Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-07-07
- Decision date
- 2025-12-04
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- PAW
- Device class
- 2
- Regulation number
- 870.3470
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bloomfield, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT (K141060) | On-X Life Technologies, Inc. | 2014-06-06 |
| CHORD-X EPTFE SUTURE (K121173) | On-Xlifetechnologies | 2012-08-16 |
Recalls involving this device
No recalls on record reference this clearance.