510(k) K042936 ยท FPA Set, Administration, Intravascular
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Nov 26, 2004 |
| Received | Oct 25, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042936
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2012 | Baxter Healthcare Corp. Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case;
For the administration of drugs Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.