510(k) K896403

MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM by Intensive Technology, Inc. — Product Code LIT

K896403 is an FDA 510(k) premarket notification submitted by Intensive Technology, Inc. for the device "MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 6, 1990. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Intensive Technology, Inc. has at least 10 other 510(k) clearances on record.