510(k) K052865 ยท DQO Catheter, Intravascular, Diagnostic
HOSPIRA CATH LAB CONVENIENCE KITS
| Applicant | Icu Medical, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Dec 22, 2005 |
| Received | Oct 11, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052865
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2012 | ICU Medical, Inc. High Pressure Stopcock (3-Way, Luer Lock, Off).
Product Usage:
For IV. Terminated |
DQO | None listed |
| Aug 2, 2012 | ICU Medical, Inc. Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets
Product Usage:
For waste managment. Terminated |
DQO | None listed |
| Aug 2, 2012 | ICU Medical, Inc. Flush Kit w 3 Way Off Stopcock
Product Usage:
Flush Kit Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.