V8 Balloon Aortic Valvuloplasty Catheter

Q: What is the product code of K152150?

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

FDA 510(k) K152150 · Intervalve, Inc.

Substantially Equivalent

510(k) numberK152150

Submission

Device name: V8 Balloon Aortic Valvuloplasty Catheter
Applicant: Intervalve, Inc.
Plymouth, MN, US
Received: August 3, 2015
Decision date: December 18, 2015
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)	Device	Applicant	Decision
K253855	KardiaPSI Balloon CatheterOZT · Traditional	Intervention Tech, Inc. ; dba Corvention	05/06/2026SE
K260437	Valvuloplasty Balloon Catheter (ValvuloPro)OZT · Special	Dongguan TT Medical, Inc.	03/20/2026SE
K241562	OutFlo Aortic Valve Dilatation Balloon CatheterOZT · Traditional	Disa Medinotec	03/11/2025SE
K240967	ValvuloPro Valvuloplasty Balloon CatheterOZT · Special	Dongguan TT Medical, Inc.	07/31/2024SE
K231814	ValvuloPro Valvuloplasty Balloon CatheterOZT · Traditional	Dongguan TT Medical, Inc.	10/12/2023SE
K220881	Inoue Balloon aOZT · Traditional	Toray Industries, Inc.	12/18/2022SE
K172932	True Flow Valvuloplasty Perfusion CatheterOZT · Traditional	C.R. Bard, Inc.	12/13/2017SE
K152613	True Flow Valvuloplasty Perfusion CatheterOZT · Traditional	C.R. Bard, Inc.	01/19/2016SE
K150667	True Dilatation Balloon Valvuloplasty CatheterOZT · Traditional	C.R. Bard, Inc.	06/17/2015SE
K142083	True Flow Valvuloplasty Perfusion CatheterOZT · Traditional	C.R. Bard, Inc.	04/17/2015SE

More from C.R. Bard, Inc.

510(k)	Device	Decision
K150343	V8 Transluminal BAV CatheterOZT · Special	04/03/2015SE
K133607	V8 Transluminal Bav CatheterOZT · Traditional	02/11/2014SE
K132728	V8 Transluminal Bav CatheterOZT · Special	11/22/2013SE
K123111	V8 Transluminal Bav CatheterOZT · Traditional	01/31/2013SE

Questions and answers

When was V8 Balloon Aortic Valvuloplasty Catheter cleared by the FDA?

V8 Balloon Aortic Valvuloplasty Catheter (K152150) received a 510(k) decision of Substantially Equivalent on December 18, 2015, 137 days after the submission was received.

What is the product code of K152150?

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