510(k) K241115

SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter by Spectrum Vascular — Product Code FOZ

K241115 is an FDA 510(k) premarket notification submitted by Spectrum Vascular for the device "SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter". The FDA issued a decision of Substantially Equivalent on November 27, 2024. 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 4 other 510(k) clearances on record.