510(k) K914299 ยท DQO Catheter, Intravascular, Diagnostic
CARDIAC CATHERIZATION KIT
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 3, 1992 |
| Received | Sep 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914299
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2012 | ICU Medical, Inc. 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and
DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655.
K914299.
Waste system. Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.