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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2017 | On-X Life Technologies, Inc. Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or con Terminated |
PAW | K141060 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.