FDA 510(k) Applications for Medical Device Product Code: OZT ()

FDA 510(k) Applications for Medical Device Product Code "OZT"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K133569	BARD PERIPHERAL VASCULAR, INC.	TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM	12/20/2013
K152613	C. R. BARD, INC.	True Flow Valvuloplasty Perfusion Catheter	01/19/2016
K172932	C. R. Bard, Inc.	True Flow Valvuloplasty Perfusion Catheter	12/13/2017
K141985	C.R. BARD, INC.	TRUE BA V BALLOON VALVULOPLASTY CATHETER	09/18/2014
K150667	C.R. Bard, Inc.	True Dilatation Balloon Valvuloplasty Catheter	06/17/2015
K142083	C.R. BARD, INC.	TRUE FLOW VALVULOPLASTY PERFUSION CATHETER	04/17/2015
K241562	DISA Medinotec	OutFlo Aortic Valve Dilatation Balloon Catheter	03/11/2025
K231814	Dongguan TT Medical, Inc	ValvuloPro Valvuloplasty Balloon Catheter	10/12/2023
K240967	Dongguan TT Medical, Inc.	ValvuloPro Valvuloplasty Balloon Catheter	07/31/2024
K142199	EDWARDS LIFESCIENCES	Ascendra Balloon Aortic Valvaloplasty Catheter	10/29/2014
K140241	EDWARDS LIFESCIENCES, LLC.	EDWARDS TRANSFEMORAL BALLOON CATHETER	07/03/2014
K133607	INTERVALVE, INC	V8 TRANSLUMINAL BAV CATHETER	02/11/2014
K123111	INTERVALVE, INC	V8 TRANSLUMINAL BAV CATHETER	01/31/2013
K132728	INTERVALVE, INC	V8 TRANSLUMINAL BAV CATHETER	11/22/2013
K152150	InterValve, Inc.	V8 Balloon Aortic Valvuloplasty Catheter	12/18/2015
K150343	InterValve, Inc.	V8 Transluminal BAV Catheter	04/03/2015
K121083	LOMA VISTA MEDICAL	TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA	10/11/2012
DEN080015	NUMED, INC.	NUCLEUS-X PTV CATHETER	06/11/2012
K122012	NUMED, INC.	Z-MED Z-MED II	10/04/2012
K220881	Toray Industries, Inc.	INOUE BALLOON A	12/18/2022