510(k) K080989 ยท FMF Syringe, Piston
UNIVERSAL VIAL ACCESS SPIKE
| Applicant | Icu Medical, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, May 2, 2008 |
| Received | Apr 7, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080989
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2020 | ICU Medical, Inc. Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260 Open, Classified |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.