BARD® BURBANK™ Carotid Bypass Shunt, 18F
BARD® BURBANK - SGA162001
Device Description
A sterile device designed to serve as a temporary blood conduit (a shunt) connecting the distal internal carotid artery to the proximal common carotid artery allowing intravascular blood to continuously flow to the patient's brain during an endarterectomy procedure. It is typically designed as a hollow shaft with atraumatic dilations (e.g., balloons) on either end. The shaft is inserted into the lumen of the blood vessel, via a small incision at the surgical site. It is typically made of silicone elastomer and polyester radiopaque materials and is available in a range of diameters. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Length: 15.5 Centimeter
- External Diameter - 18 French to 12 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DWF
Device Name: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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: 870.4210
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 10801741090230
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00801741090233
Package Quantity: 5
Package Discontinue Date: 11/30/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: CA
Device Id: 00801741090233
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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