510(k) K180846 ยท DQO Catheter, Intravascular, Diagnostic
Arterial Pressure Monitoring Set/Tray
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Unknown, Dec 19, 2018 |
| Received | Apr 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180846
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419 Open, Classified |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.