510(k) K024107

FEMOSTOP FEMORAL COMPRESSION SYSTEM by Radi Medical Systems AB — Product Code DXC

K024107 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "FEMOSTOP FEMORAL COMPRESSION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 24, 2002. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Radi Medical Systems AB has at least 10 other 510(k) clearances on record.