SO049 Z-MED 22X3X120

SO049 Z
Z-MED™ - 611809

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

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LIT

Device Name: Catheter, Angioplasty, Peripheral, Transluminal

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.1250

Third Party Flag: Y

Medical Specialty: CV

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 Id: 04046964338427

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