- Physicians Office Resource

Recanalization System, Refurbished
Recanalization System - BDRECANSYSTEMR

Device Description

A mains electricity (AC-powered) component of a mechanical atherectomy system designed to generate a high frequency electrical current that is converted via a separate transducer, typically within a handpiece, into vibrational energy for the fragmentation of a chronic partial occlusion (CPO) or chronic total occlusion (CTO) of both coronary and peripheral arteries during an atherectomy procedure. The device may be operated via a foot-switch and may include an integrated suction/aspiration system.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: PDU

Device Name: Catheter For Crossing Total Occlusions

Device Class: 2

Physical State: Peripheral catheter

Definition: To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Creates narrow channel in occlusion to allow for guidewire placement for further percutaneous intervention, such as angioplasty, atherectomy or stent placement.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral vasculature

Regulation Number: 870.1250

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 00801741202438

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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