ClearanceBrief
510(k) K261455 ยท DQO Catheter, Intravascular, Diagnostic

Arterial Pressure Monitoring Set/Tray

ApplicantSpectrum Vascular, White Plains NY, US
DecisionSubstantially Equivalent, Jun 26, 2026
ReceivedMay 1, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K261455

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.