510(k) K982182

FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 by Radi Medical Systems AB — Product Code DXC

K982182 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0". The FDA issued a decision of Substantially Equivalent on September 18, 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.