VIDA™ PTV Dilatation Catheter, 12mm x 4cm, 100cm catheter

VIDA™ PTV Dilatation Catheter, 12mm x 4cm, 100cm catheter
VIDA - VDA100124

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.

No Data Available

• Balloon Diameter, 12 Millimeters
• Shaft Length, 100 Centimeters
• Balloon Length, 4 Centimeters

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OMZ

Device Name: Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

Device Class: 2

Physical State: The device is a catheter with a balloon tip.

Definition: Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve. Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Catheter contains a ballon at the distal end of the shaft. The catheter is inserted into the body and directed towards the pulmonary 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 target area is the pulmonary valve of the heart.

Regulation Number: 870.1250

Third Party Flag: N

Medical Specialty: CV

Device Id: 00801741090806

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