510(k) K984590 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
0.9% SODIUM CHLORIDE FLUSH SYRINGE
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Oct 7, 1999 |
| Received | Dec 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984590
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2003 | Baxter Healthcare Corp. 0.9% Sodium Chloride Flush Syringe; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.