510(k) K972512

SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL by Boston Scientific Scimed, Inc. — Product Code LIT

K972512 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL". The FDA issued a decision of Substantially Equivalent on February 12, 1998. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Boston Scientific Scimed, Inc. has at least 10 other 510(k) clearances on record.