510(k) K853536

VELCRO FISTULA PRESSURE CLAMPS by Cp Medical — Product Code KXM

K853536 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "VELCRO FISTULA PRESSURE CLAMPS". The FDA issued a decision of Substantially Equivalent on October 17, 1985. The device falls under product code KXM (System Accessories, Extracorporeal), a Class II device regulated under 21 CFR 876.5820. Cp Medical has at least 10 other 510(k) clearances on record.