510(k) K911639

OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE by Vas-Cath, Inc. — Product Code LIT

K911639 is an FDA 510(k) premarket notification submitted by Vas-Cath, Inc. for the device "OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE". The FDA issued a decision of Substantially Equivalent on June 11, 1991. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Vas-Cath, Inc. has at least 10 other 510(k) clearances on record.