CATH ADVANCE ASPIR EXPORT ADVANCE NSR

CATH ADVANCE ASPIR EXPORT ADVANCE NSR
Export Advance™ - ADVANCE

A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

• Length: 140.0 Centimeter
• Lumen/Inner Diameter: 1.78 Millimeter
• Catheter Gauge: 6.0 French

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KRA

Device Name: Catheter, Continuous Flush

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: 870.1210

Third Party Flag: Y

Medical Specialty: CV

Code: QEZ

Device Name: Aspiration Thrombectomy Catheter

Device Class: 2

Physical State: Peripheral and/or coronary catheter

Definition: To remove thrombus from the peripheral and/or coronary vasculature through aspiration.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: removed thrombus from the vasculature

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral and/or coronary vasculature

Regulation Number: 870.5150

Third Party Flag: N

Medical Specialty: CV

Device Id: 00643169647343

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