Cleared Special

V8 Transluminal BAV Catheter

K150343 · Intervalve, Inc. · Cardiovascular

Apr 2015

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K150343 is an FDA 510(k) clearance for the V8 Transluminal BAV 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 April 3, 2015, 51 days after receiving the submission on February 11, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1255.

Submission Details

510(k) Number	K150343 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2015
Decision Date	April 03, 2015
Days to Decision	51 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.