FDA.reportPublic FDA data

510(k) K241562

Device
OutFlo Aortic Valve Dilatation Balloon Catheter
Applicant
Disa Medinotec
510(k) number
K241562
Product code
OZT
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-11
Date received
2024-05-31
Regulation
870.1255
Classification name
Balloon Aortic Valvuloplasty
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Lyndon Oldfield
Address
Stand 171, Northlands Business Park, Bush Telegraph St. Northriding Johannesburg ZA 2169 2169

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OZT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253855KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba Corvention2026-05-06
K260437Valvuloplasty Balloon Catheter (ValvuloPro)Dongguan TT Medical, Inc.2026-03-20
K240967ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.2024-07-31
K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.2023-10-12
K220881INOUE BALLOON AToray Industries, Inc.2022-12-18
K172932True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc.2017-12-13
K152613True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc.2016-01-19
K152150V8 Balloon Aortic Valvuloplasty CatheterIntervalve, Inc.2015-12-18
K150667True Dilatation Balloon Valvuloplasty CatheterC.R. Bard, Inc.2015-06-17
K142083TRUE FLOW VALVULOPLASTY PERFUSION CATHETERC.R. Bard, Inc.2015-04-17
K150343V8 Transluminal BAV CatheterIntervalve, Inc.2015-04-03
K142199Ascendra Balloon Aortic Valvaloplasty CatheterEdwards Lifesciences2014-10-29
K141985TRUE BA V BALLOON VALVULOPLASTY CATHETERC.R. Bard, Inc.2014-09-18
K140241EDWARDS TRANSFEMORAL BALLOON CATHETEREdwards Lifesciences, LLC2014-07-03
K133607V8 TRANSLUMINAL BAV CATHETERIntervalve, Inc.2014-02-11