510(k) K080077 ยท FMG Stopcock, I.V. Set
CLAVE STOPCOCK
| Applicant | Icu Medical, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Feb 13, 2008 |
| Received | Jan 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080077
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2020 | ICU Medical, Inc. NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(10)4572842.
The ICU Medical Clave Stopcock is a device used to administer or wi Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)241201(30)50(10)4493459;(01)10887709053172(17)241201(30)50(10)453667 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case.
UDI:(01)10887709053189(17)241201(30)50(10)4537253;(01)10887709053189(17)250101(3 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case.
UDI:(01)10887709039916(17)250201(30)50(10)4727496.
The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids th Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.