510(k) K260165

Unimpregnated Central Venous Catheter by Spectrum Vascular — Product Code FOZ

K260165 is an FDA 510(k) premarket notification submitted by Spectrum Vascular for the device "Unimpregnated Central Venous Catheter". The FDA issued a decision of Substantially Equivalent on August 10, 2026. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Spectrum Vascular has at least 5 other 510(k) clearances on record.