Device
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...
Manufacturer
DISA MEDINOTEC (PTY) LTD
DISA MEDINOTEC (PTY) LTD
Model: OTF1-18040
DI: 06009698453789
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
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.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
806ecb6c-2500-41a7-94c7-30817d383bf7
Distribution Status:
In Commercial Distribution
DUNS Number:
539157634
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06009698453789
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 17453
Name: Cardiac valvuloplasty catheter
Definition:
A 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.
FDA Product Codes
OZT
Balloon Aortic Valvuloplasty
Premarket Submissions
Submission Number:
K241562
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Millimeter
Device Size - Size - @attributes - Value:
20
Device Size - Size Type:
Balloon Diameter
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
5
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
25
Storage Handling - Storage Handling Type:
Storage Environment Temperature