510(k) K070532 ยท FPA Set, Administration, Intravascular
SPIROS
| Applicant | Icu Medical, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 20, 2007 |
| Received | Feb 26, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070532
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2020 | ICU Medical, Inc. 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN ( Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.