510(k) K092361

REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER by Invatec S.P.A. — Product Code LIT

K092361 is an FDA 510(k) premarket notification submitted by Invatec S.P.A. for the device "REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on October 29, 2009. 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.