Flow Diverter System

Flow Diverter System
Surpass Elite - FDSE45035

A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.

• Length: 35.0 Millimeter
• Lumen/Inner Diameter: 4.5 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OUT

Device Name: Intracranial Aneurysm Flow Diverter

Device Class: 3

Physical State: metallic

Definition: Treatment of wide-necked and larger or giant intracranial aneurysms.

Submission Type ID: 2

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: interventional

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: neurovasculature

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 07613327587852

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