510(k) K821515 ยท FPA Set, Administration, Intravascular
VENTED NITROGLYCERIN I.V. SET
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 9, 1982 |
| Received | May 20, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821515
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2010 | Hospira Inc. Latex-free, Nitroglycerin Primary I.V. Pump Set, convertible pin, 107 inch with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 1199 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.