510(k) K911870

SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH by Scimed Life Systems, Inc. — Product Code LIT

K911870 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH". The FDA issued a decision of Substantially Equivalent on Aug 12, 1991. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.