510(k) K053524 ยท FZP Clip, Implantable
C-PORT DISTAL ANASTOMOSIS SYSTEM
| Applicant | Cardica, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Nov 16, 2006 |
| Received | Dec 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053524
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2018 | AESDEX AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100.
The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small Terminated |
FZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.