510(k) K974175 ยท DWZ Device, Biopsy, Endomyocardial
HEARTPORT ENDOAORTIC CLAMP CATHETER
| Applicant | Heartport, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Dec 16, 1997 |
| Received | Nov 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974175
| 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 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 |
| May 10, 2005 | Heartport, Inc. The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device. Terminated |
DWZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.