V8 Transluminal Bav Catheter

FDA 510(k) K133607 · Intervalve, Inc.

Substantially Equivalent

510(k) numberK133607

Submission

Device name
V8 Transluminal Bav Catheter
Applicant
Intervalve, Inc.
Minneapolis, MN, US
Received
November 25, 2013
Decision date
February 11, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OZT – Balloon Aortic Valvuloplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1255
Specialty
Cardiovascular

A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.

Other 510(k)s with product code OZT

510(k)DeviceApplicantDecision
K253855KardiaPSI Balloon CatheterOZT · Traditional Intervention Tech, Inc. ; dba Corvention05/06/2026SE
K260437Valvuloplasty Balloon Catheter (ValvuloPro)OZT · Special Dongguan TT Medical, Inc.03/20/2026SE
K241562OutFlo Aortic Valve Dilatation Balloon CatheterOZT · Traditional Disa Medinotec03/11/2025SE
K240967ValvuloPro Valvuloplasty Balloon CatheterOZT · Special Dongguan TT Medical, Inc.07/31/2024SE
K231814ValvuloPro Valvuloplasty Balloon CatheterOZT · Traditional Dongguan TT Medical, Inc.10/12/2023SE
K220881Inoue Balloon aOZT · Traditional Toray Industries, Inc.12/18/2022SE
K172932True Flow Valvuloplasty Perfusion CatheterOZT · Traditional C.R. Bard, Inc.12/13/2017SE
K152613True Flow Valvuloplasty Perfusion CatheterOZT · Traditional C.R. Bard, Inc.01/19/2016SE
K152150V8 Balloon Aortic Valvuloplasty CatheterOZT · Traditional Intervalve, Inc.12/18/2015SE
K150667True Dilatation Balloon Valvuloplasty CatheterOZT · Traditional C.R. Bard, Inc.06/17/2015SE

More from C.R. Bard, Inc.

510(k)DeviceDecision
K152150V8 Balloon Aortic Valvuloplasty CatheterOZT · Traditional 12/18/2015SE
K150343V8 Transluminal BAV CatheterOZT · Special 04/03/2015SE
K132728V8 Transluminal Bav CatheterOZT · Special 11/22/2013SE
K123111V8 Transluminal Bav CatheterOZT · Traditional 01/31/2013SE

Questions and answers

When was V8 Transluminal Bav Catheter cleared by the FDA?

V8 Transluminal Bav Catheter (K133607) received a 510(k) decision of Substantially Equivalent on February 11, 2014, 78 days after the submission was received.

What is the product code of K133607?

The FDA product code is OZT – Balloon Aortic Valvuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.1255.