- Physicians Office Resource

Embolic Protection Device
SpiderFX - SPD2-US-040-190

Device Description

A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Keep dry

Device Sizes

Length: 190 Centimeter

Outer Diameter: 4 Millimeter

Outer Diameter: .014 Inch

Length: 190 Centimeter
Outer Diameter: 4 Millimeter
Outer Diameter: .014 Inch

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NFA

Device Name: Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

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: 870.1250

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 00821684040492

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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