510(k) K884318 ยท KRB Probe, Thermodilution
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Dec 13, 1988 |
| Received | Oct 13, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2018 | ICU Medical, Inc. Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090 Terminated |
KRB | None listed |
| Oct 5, 2018 | ICU Medical, Inc. Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090 Terminated |
KRB | None listed |
| Oct 5, 2018 | ICU Medical, Inc. Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645 Terminated |
KRB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.