510(k) K252126
K252126 is an FDA 510(k) premarket notification submitted by Chawla Heart Technologies, LLC for the device "MitraPatch Mitral Valve Repair System". The FDA issued a decision of Substantially Equivalent on December 4, 2025. The device falls under product code PAW (Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement), a Class II device regulated under 21 CFR 870.3470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2025
- Date Received
- July 7, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
- Device Class
- Class II
- Regulation Number
- 870.3470
- Review Panel
- CV
- Submission Type
To repair or replace chordae tendinae.