510(k) K254278 ยท DQO Catheter, Intravascular, Diagnostic
Arterial Pressure Monitoring Set/Tray
| Applicant | Spectrum Vascular, White Plains NY, US |
| Decision | Substantially Equivalent, Mar 25, 2026 |
| Received | Dec 30, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254278
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.