510(k) K121442 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
| Applicant | Cordis Corporation, Bridgewater NJ, US |
| Decision | Substantially Equivalent, Jun 14, 2012 |
| Received | May 15, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2018 | Cordis Corporation Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obs Terminated |
LIT | None listed |
| Jan 16, 2015 | Cordis Corporation Cordis POWERFLEX PRO PTA Dilatation Catheter
Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of Terminated |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.