510(k) K912103 ยท FPK Tubing, Fluid Delivery
LIFESHIELD EXTENSION SET
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Dec 13, 1991 |
| Received | May 13, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912103
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Secondary I.V. Set, convertible pin, 32 inch with OPTION-LOK, drop-in blunt cannula and Snap Lok, 15 drops/mL, a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Terminated |
FPA | None listed |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 15 different sets listed in the code information section below. Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.