510(k) K141060 ยท PAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
| Applicant | On-X Life Technologies, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jun 6, 2014 |
| Received | Apr 24, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141060
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.