510(k) K254278

Arterial Pressure Monitoring Set/Tray by Spectrum Vascular — Product Code DQO

K254278 is an FDA 510(k) premarket notification submitted by Spectrum Vascular for the device "Arterial Pressure Monitoring Set/Tray". The FDA issued a decision of Substantially Equivalent on March 25, 2026. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Spectrum Vascular has at least 4 other 510(k) clearances on record.