510(k) K012128 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
PROTECTIV ACUVANCE IV CATHETER SYSTEM
| Applicant | Ethicon Endo-Surgery, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Aug 1, 2001 |
| Received | Jul 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012128
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2016 | Smiths Medical ASD Inc. Acuvance2 Safety Catheter, Product No. 1720-AI
Product Usage:
The Acuvance 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all patient Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.