FDA Product Code
FDA Product Code PAW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3470
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252126 | MitraPatch Mitral Valve Repair System | Chawla Heart Technologies, LLC | 2025-12-04 | Traditional | PDF ↗ |
| K141060 | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT | On-X Life Technologies, Inc. | 2014-06-06 | Special | PDF ↗ |
| K121173 | CHORD-X EPTFE SUTURE | On-Xlifetechnologies | 2012-08-16 | Abbreviated | PDF ↗ |
Product code PAW · Class II · Cardiovascular. Data: openFDA.