510(k) K971293 ยท FPA Set, Administration, Intravascular
LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
| Applicant | Abbott Mfg., Inc., Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 27, 1997 |
| Received | Apr 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971293
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2003 | Abbott Laboratories HPD/ADD Primary I.V. Gravity Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 95 different sets listed in the code information section below. Please not Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.