510(k) K983471

FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER by Radi Medical Systems AB — Product Code DXC

K983471 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER". The FDA issued a decision of Substantially Equivalent on February 23, 1999. 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.