510(k) K974589 ยท FPA Set, Administration, Intravascular
SMARTVALVE
| Applicant | Icu Medical, Inc., San Clemente CA, US |
| Decision | Substantially Equivalent, Jan 9, 1998 |
| Received | Dec 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974589
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | ICU Medical, Inc. IV Sets with drip chambers Open, Classified |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709040141(17)250101(30)25(10)4573652.
The SmartValve Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709076119(17)250101(30)25(10)4584862.
The SmartValve is a single use, ster Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.