510(k) K870866 ยท FPA Set, Administration, Intravascular
THE GRIPPER(TM) PORT-A-CATH NEEDLES
| Applicant | Pharmacia, Inc., Piscataway NJ, US |
| Decision | Substantially Equivalent, Jun 25, 1987 |
| Received | Mar 3, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2019 | Smiths Medical ASD Inc. GRIPPER Needles sold individually. Labeled as the following item descriptions:
1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX;
2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX;
3. NDL, GRIPPER, 20G X 1.2 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.