Cleared Traditional

V8 Balloon Aortic Valvuloplasty Catheter

K152150 · Intervalve, Inc. · Cardiovascular

Dec 2015

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K152150 is an FDA 510(k) clearance for the V8 Balloon Aortic Valvuloplasty Catheter, a Balloon Aortic Valvuloplasty (Class II — Special Controls, product code OZT), submitted by Intervalve, Inc. (Plymouth, US). The FDA issued a Cleared decision on December 18, 2015, 137 days after receiving the submission on August 3, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1255.

Submission Details

510(k) Number	K152150 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2015
Decision Date	December 18, 2015
Days to Decision	137 days
Submission Type	Traditional
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.