Product Code: OZT FDA class 2 21 CFR 870.1255

Balloon Aortic Valvuloplasty

Cardiovascular

The Balloon Aortic Valvuloplasty device is a cardiovascular catheter indicated for balloon valvuloplasty of the aortic valve, a procedure used to dilate a stenotic aortic valve and relieve obstruction to blood flow. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OZT, with regulation number 870.1255 under the Cardiovascular medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OZT
Device Class: FDA class 2
Regulation Number: 870.1255
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253855	KardiaPSI Balloon Catheter	May 06, 2026	Substantially Equivalent	Intervention Tech, Inc. ; dba Corvention
K260437	Valvuloplasty Balloon Catheter (ValvuloPro)	Mar 20, 2026	Substantially Equivalent	Dongguan TT Medical, Inc.
K241562	OutFlo Aortic Valve Dilatation Balloon Catheter	Mar 11, 2025	Substantially Equivalent	Disa Medinotec
K240967	ValvuloPro Valvuloplasty Balloon Catheter	Jul 31, 2024	Substantially Equivalent	Dongguan TT Medical, Inc.
K231814	ValvuloPro Valvuloplasty Balloon Catheter	Oct 12, 2023	Substantially Equivalent	Dongguan TT Medical, Inc.
K220881	INOUE BALLOON A	Dec 18, 2022	Substantially Equivalent	Toray Industries, Inc.
K172932	True Flow Valvuloplasty Perfusion Catheter	Dec 13, 2017	Substantially Equivalent	C.R. Bard, Inc.
K152613	True Flow Valvuloplasty Perfusion Catheter	Jan 19, 2016	Substantially Equivalent	C.R. Bard, Inc.
K152150	V8 Balloon Aortic Valvuloplasty Catheter	Dec 18, 2015	Substantially Equivalent	Intervalve, Inc.
K150667	True Dilatation Balloon Valvuloplasty Catheter	Jun 17, 2015	Substantially Equivalent	C.R. Bard, Inc.
K142083	TRUE FLOW VALVULOPLASTY PERFUSION CATHETER	Apr 17, 2015	Substantially Equivalent	C.R. Bard, Inc.
K150343	V8 Transluminal BAV Catheter	Apr 03, 2015	Substantially Equivalent	Intervalve, Inc.
K142199	Ascendra Balloon Aortic Valvaloplasty Catheter	Oct 29, 2014	Substantially Equivalent	Edwards Lifesciences
K141985	TRUE BA V BALLOON VALVULOPLASTY CATHETER	Sep 18, 2014	Substantially Equivalent	C.R. Bard, Inc.
K140241	EDWARDS TRANSFEMORAL BALLOON CATHETER	Jul 03, 2014	Substantially Equivalent	Edwards Lifesciences, LLC
K133607	V8 TRANSLUMINAL BAV CATHETER	Feb 11, 2014	Substantially Equivalent	Intervalve, Inc.
K133569	TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM	Dec 20, 2013	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K132728	V8 TRANSLUMINAL BAV CATHETER	Nov 22, 2013	Substantially Equivalent	Intervalve, Inc.
K123111	V8 TRANSLUMINAL BAV CATHETER	Jan 31, 2013	Substantially Equivalent	Intervalve, Inc.
K121083	TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA	Oct 11, 2012	Substantially Equivalent	Loma Vista Medical
K122012	Z-MED Z-MED II	Oct 04, 2012	Substantially Equivalent	NuMED, Inc.
DEN080015	NUCLEUS-X PTV CATHETER	Jun 11, 2012	Unknown	NuMED, Inc.