510(k) K955132 ยท DXC Clamp, Vascular
HEARTPORT ENDOAORTIC CLAMP
| Applicant | Heartport, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Jun 7, 1996 |
| Received | Nov 9, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2009 | Edwards Lifesciences Research Medical, Inc. EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic catheter 100 cm, REF EC1001, Sterile EO, Sterile
R, Edwards Lifesciences LLC Irvine, CA***". The device is a 10.5Fr Terminated |
DXC | None listed |
| Nov 6, 2009 | Edwards Lifesciences Research Medical, Inc. EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edwards
Lifesciences LLC Irvine, CA 92614-5686" The device is a 10.5Fr wirewound, t Terminated |
DXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.