510(k) K980898

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

K980898 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER". The FDA issued a decision of Substantially Equivalent on April 21, 1998. 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.