510(k) K023880 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Dec 11, 2002 |
| Received | Nov 21, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023880
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2011 | Edwards Lifesciences, LLC Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access Systems.
Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for Terminated |
DWF | None listed |
| Jan 28, 2011 | Edwards Lifesciences Llc Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614.
The Steerable Coronary Sinus Catheter is a three-lumen, 9 Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.