510(k) K133569

TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM by Bard Peripheral Vascular, Inc. — Product Code OZT

K133569 is an FDA 510(k) premarket notification submitted by Bard Peripheral Vascular, Inc. for the device "TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM". The FDA issued a decision of Substantially Equivalent on December 20, 2013. The device falls under product code OZT (Balloon Aortic Valvuloplasty), a Class II device regulated under 21 CFR 870.1255. Bard Peripheral Vascular, Inc. has at least 10 other 510(k) clearances on record.