510(k) K110193

FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F by St. Jude Medical Systems AB — Product Code DXC

K110193 is an FDA 510(k) premarket notification submitted by St. Jude Medical Systems AB for the device "FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F". The FDA issued a decision of Substantially Equivalent on February 24, 2011. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. St. Jude Medical Systems AB has at least 4 other 510(k) clearances on record.