510(k) K882503 ยท FPA Set, Administration, Intravascular
30 IV EXTENSION SET W/TWO MALE LUER LOCKS
| Applicant | Churchill Medical Systems, Inc., Horsham PA, US |
| Decision | Substantially Equivalent, Aug 25, 1988 |
| Received | Jun 17, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882503
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 3, 2017 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF.
Kit used when administering IV during emergency. Terminated |
LRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.