PAW
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Medical specialty
- Cardiovascular
- Flags
- Implant · Life-sustaining
- FDA definition
- To repair or replace chordae tendinae.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MitraPatch Mitral Valve Repair System (K252126) | Chawla Heart Technologies, LLC | 2025-12-04 |
| 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 |
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Every clearance here is in the API, with alerts when new ones post.