- Physicians Office Resource

Embolization Device
Pipeline - FA-77250-10

Device Description

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.

Environmental Conditions

Special Storage Condition, Specify

Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT

Device Sizes

Length: 10 Millimeter

Usable Length,190,Centimeter;

Outer Diameter: 2.50 Millimeter

Length: 10 Millimeter
Usable Length,190,Centimeter;
Outer Diameter: 2.50 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 00836462014084

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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