VIDA® BAV Balloon Valvuloplasty Catheter, 22mm x 4cm, 100cm catheter


Product Overview

VIDA® BAV Balloon Valvuloplasty Catheter, 22mm x 4cm, 100cm catheter
VIDA® - BAV224010


Device Description

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.


Environmental Conditions

No Data Available


Device Sizes

  • Balloon Length, 4 Centimeters
  • Balloon Diameter, 22 Centimeters
  • Shaft Length, 100 Centimeters
    • Balloon Length, 4 Centimeters
    • Balloon Diameter, 22 Centimeters
    • Shaft Length, 100 Centimeters


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OZT

    Device Name: Balloon Aortic Valvuloplasty

    Device Class: 2

    Physical State: Generally, a balloon aortic valvuloplasty catheter is a coaxial catheter comprised of outer and inner layers. The catheter features a molded proximal end bifurcated with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. Upon reaching a specified pressure, the waist will expand to the rated balloon diameter and dilate the valve to the rated diameter.

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

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: The catheter is inserted into the body and directed towards the aortic valve. Once the catheter is placed in the valve, the balloon is expanded which compresses and/or breaks the material causing stenosis.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: The aortic valve of the heart.

    Regulation Number: 870.1255

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00801741127878

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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