510(k) K031361 ยท FPA Set, Administration, Intravascular
CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
| Applicant | Deltec, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, May 23, 2003 |
| Received | Apr 30, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2023 | Smiths Medical ASD Inc. CADD Administration Set, List Numbers:
a) REF 21-7346-24;
b) REF 21-7363-24 Open, Classified |
FPA | None listed |
| Jul 14, 2020 | Smiths Medical ASD Inc. CADD Administration Sets, Model #21-7346-24 Terminated |
FPA | None listed |
| May 15, 2017 | Smiths Medical ASD Inc. CADD High Volume Administration Set with FlowStop, 21-7381-24.
Product Usage:
The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid deliver from an IV b Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.