510(k) K801478

SSC8 SORENSON SUBCLAVIAN CATHETER by Sorensen Research — Product Code FIQ

K801478 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "SSC8 SORENSON SUBCLAVIAN CATHETER". The FDA issued a decision of Substantially Equivalent on August 27, 1980. The device falls under product code FIQ (Cannula, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Sorensen Research has at least 10 other 510(k) clearances on record.