510(k) K964248 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
HEARTPORT ENDOCORONARY SINUS CATHETR
| Applicant | Heartport, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Oct 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964248
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2011 | Edwards Lifesciences, LLC Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA.
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 EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA 92614.
The EndoPlege coronary sinus catheter is a three-lumen, 9 F Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.