510(k) K082806 ยท FPA Set, Administration, Intravascular
SPINNING SPIROS, MODEL CH-2000
| Applicant | Icu Medical, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Apr 6, 2009 |
| Received | Sep 24, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082806
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2022 | ICU Medical, Inc. 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP.
Accessory for intravascular administration set. Open, Classified |
FPA | None listed |
| Mar 16, 2021 | ICU Medical, Inc. REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of fluids from a conta Open, Classified |
FPA | None listed |
| Mar 16, 2021 | ICU Medical, Inc. REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets Open, Classified |
FPA | None listed |
| Mar 16, 2021 | ICU Medical, Inc. REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or cathete Open, Classified |
FPA | None listed |
| Aug 31, 2020 | ICU Medical, Inc. 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Lu Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.