FDA cleared the Unimpregnated Central Venous Catheter from Spectrum Vascular on Aug 10, 2026 under K260165, a traditional 510(k). The device falls under product code FOZ, Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, regulated at 21 CFR 880.5200 as a Class 2 device. The review panel was General Hospital.
FDA logged the submission as received on Jan 20, 2026. The decision came 202 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Spectrum Vascular has 3 other decisions in the tracker over the last 12 months: K261455 (Arterial Pressure Monitoring Set/Tray), K254278 (Arterial Pressure Monitoring Set/Tray), K252373 (BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology).