510(k) K961552 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
CVP POLYURETHANE CATHETER
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | Apr 22, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2004 | Abbott Laboratories HPD/ADD/GPRD 18 Gauge thin wall needle as part of a Central Venous Catheter Kit Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.