Z695 Atrio Balloon Catheter 9.5mm

Z695 Atrio Balloon Catheter 9.5mm
Z-6™ - 611050

Device Description

A flexible tube with an inflatable balloon designed to create or enlarge the atrial septal defect found in the hearts of infants with congenital cardiac malformations. This allows interatrial blood mixing in infants with transposition of the great vessels. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

KEEP AWAY FROM SUNLIGHT

Storage Environment Temperature - Degrees Celsius

22.00
20.00

Device Sizes

Diameter (mm) : 9.500 MM

Length : 9.500 MM

Length of catheter : 50.000 CM

Diameter (mm) : 9.500 MM
Length : 9.500 MM
Length of catheter : 50.000 CM

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DXF

Device Name: Catheter, Septostomy

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: 870.5175

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 04046955718047

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