510(k) K991301 ยท FPA Set, Administration, Intravascular
CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1
| Applicant | Sims Deltec, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jun 9, 1999 |
| Received | Apr 16, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991301
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2012 | Smiths Medical ASD, Inc. CADD High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made in Mexico, Smith Medical ASD, Inc., 1265 Grey Fox Road, St Paul, Minnesota 55112. Designed for use with CADD pumps to Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.