PAW
- Product code
- PAW
- Device name
- Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.3470
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Implant
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 3 (all years; only the last 3 years are listed here)
FDA classification definition
To repair or replace chordae tendinae.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252126 | 2025-12-04 | Chawla Heart Technologies, LLC | MitraPatch Mitral Valve Repair System |
Official FDA classification page: PAW
Classification and pathway per current FDA publications. Data from openFDA (CC0).