510(k) K992532 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
| Applicant | Baxter Healthcare Corp, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 13, 2000 |
| Received | Jul 29, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992532
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2006 | Edwards Lifesciences Corporation of Puerto Rico Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S Terminated |
FOZ | None listed |
| Dec 24, 2003 | Edwards Lifesciences Corporation of Puerto Rico Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.