FDA.reportPublic FDA data

OutFlo Aortic Valve Valvuloplasty Dilatation Balloon Catheter

Primary DI
06009698453819
Brand
OutFlo Aortic Valve Valvuloplasty Dilatation Balloon Catheter
Company
DISA MEDINOTEC (PTY) LTD
Model
OTF1-25040
Device description
The OutFlo Aortic Valve Valvuloplasty Dilatation Balloon Catheter is a sterile single-use device used during balloon aortic valvuloplasty to dilate a stenotic aortic valve as well as a pre and post dilatation device for the placement of TAVI (Transcatheter aortic valve implantation) heart valves.
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZTBalloon Aortic Valvuloplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZTBalloon Aortic ValvuloplastyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241562000OutFlo Aortic Valve Dilatation Balloon CatheterDisa Medinotec2025-03-11OZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009698453819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009698453819060096984538196009698453819

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac valvuloplasty catheterA sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter25Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+27873302301info@disamedinotec.com

Regulatory Flags#

DUNS number
539157634
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009698453161Trachealator Non-occlusive Airway Dilation BalloonTRD1-145402026-05-20
06009698453178Trachealator Non-occlusive Airway Dilation BalloonTRD1-160402026-05-20
06009698453185Trachealator Non-occlusive Airway Dilation BalloonTRD1-180402026-05-20
06009698453208Trachealator Non-occlusive Airway Dilation BalloonTRD1-070302026-05-20
06009698453215Trachealator Non-occlusive Airway Dilation BalloonTRD1-080302026-05-20
06009698453222Trachealator Non-occlusive Airway Dilation BalloonTRD1-090302026-05-20
06009698453239Trachealator Non-occlusive Airway Dilation BalloonTRD1-100302026-05-20
06009698453246Trachealator Non-occlusive Airway Dilation BalloonTRD1-120402026-05-20
06009698453789OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterOTF1-180402026-05-20
06009698453796OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterOTF1-200402026-05-20
06009698453802OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterOTF1-230402026-05-20
06009698453826OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterOTF1-280402026-05-20
06009698453192Trachealator Non-occlusive Airway Dilation BalloonTRD1-060302026-05-19
06009698450009TrachealatorTRD12023-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009698453789OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOZT2026-05-20
06009698453796OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOZT2026-05-20
06009698453802OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOZT2026-05-20
06009698453826OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOZT2026-05-20
06934184005060ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
06934184005077ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
06934184005084ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
06934184005091ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
06934184005107ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
06934184005114ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
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14960685201235INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01
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