510(k) K073318

BIPORE BALLOON DILATION CATHETER by Bipore, Inc. — Product Code LIT

K073318 is an FDA 510(k) premarket notification submitted by Bipore, Inc. for the device "BIPORE BALLOON DILATION CATHETER". The FDA issued a decision of Substantially Equivalent on January 16, 2008. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Bipore, Inc. has at least 9 other 510(k) clearances on record.