Cleared Special

TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM

K133569 · Bard Peripheral Vascular, Inc. · Cardiovascular

Dec 2013

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K133569 is an FDA 510(k) clearance for the TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM, a Balloon Aortic Valvuloplasty (Class II — Special Controls, product code OZT), submitted by Bard Peripheral Vascular, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 20, 2013, 30 days after receiving the submission on November 20, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1255.

Submission Details

510(k) Number	K133569 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2013
Decision Date	December 20, 2013
Days to Decision	30 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	OZT — Balloon Aortic Valvuloplasty
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1255
Definition	A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve.