510(k) K964161 ยท DXC Clamp, Vascular
HEARTPORT ENDOAORTIC CLAMP
| Applicant | Heartport, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Apr 4, 1997 |
| Received | Oct 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964161
| 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 |
| Jan 5, 2009 | Edwards Lifesciences Research Medical, Inc. Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Edwards Lifesciences LLC, Irvine, CA 92614. This product is indicated for use in p Terminated |
DXC | None listed |
| Jan 5, 2009 | Edwards Lifesciences Research Medical, Inc. CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. This product is indicated Terminated |
DXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.