510(k) K060142

VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS by Vascutek, Ltd. — Product Code DSY

K060142 is an FDA 510(k) premarket notification submitted by Vascutek, Ltd. for the device "VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS". The FDA issued a decision of Substantially Equivalent on February 7, 2006. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), a Class II device regulated under 21 CFR 870.3450. Vascutek, Ltd. has at least 10 other 510(k) clearances on record.