Recanalization System Footswitch

Recanalization System Footswitch
Recanalization System - BDRECANFOOT

An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00801741202414

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