Panels › Cardiovascular › Product code PAW · Class 2
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Regulation 870.3470
1510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PAW
| Company | 510(k)s | Recalls |
|---|---|---|
| On-X Life Technologies, Inc. | 1 | 1 |
| Chawla Heart Technologies, LLC | 1 | 0 |
| On-Xlifetechnologies | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 4, 2025 | K252126 | MitraPatch Mitral Valve Repair System Chawla Heart Technologies, LLC | PAW |
| Jun 6, 2014 | K141060 | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT On-X Life Technologies, Inc. | PAW |
| Aug 16, 2012 | K121173 | CHORD-X EPTFE SUTURE On-Xlifetechnologies | PAW |
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