CATHETER 007161 WVN 5268S 4 50 ST RASHSL

CATHETER 007161 WVN 5268S 4 50 ST RASHSL
Rashkind - 007161

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

Store catheters in a cool, dry area.

Device Sizes

Lumen/Inner Diameter: 0.457 Millimeter

Length: 50.0 Centimeter

Catheter Gauge: 4.0 French

Lumen/Inner Diameter: 0.457 Millimeter
Length: 50.0 Centimeter
Catheter Gauge: 4.0 French

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: 00613994760272

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