510(k) K914531 ยท DQX Wire, Guide, Catheter
STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Feb 27, 1992 |
| Received | Oct 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914531
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2024 | ARROW INTERNATIONAL Inc. Arrow Arterial Kits and Trays as follows:
(1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1;
(2) Arrow Arterial Access Tray with 0.021" Spring- Open, Classified |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.