510(k) K100921

ADMIRAL XTREME PTA BALLOON DILATATION CATHETER by Invatec S.P.A. — Product Code LIT

K100921 is an FDA 510(k) premarket notification submitted by Invatec S.P.A. for the device "ADMIRAL XTREME PTA BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on April 30, 2010. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Invatec S.P.A. has at least 3 other 510(k) clearances on record.