- Physicians Office Resource

CATH ADVANCE ASPIR EXPORT ADVANCE NSR
Export Advance™ - ADVANCE

Device Description

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.

Environmental Conditions

Special Storage Condition, Specify

Store catheters in a cool, dry place.

Device Sizes

Length: 140.0 Centimeter

Lumen/Inner Diameter: 1.78 Millimeter

Catheter Gauge: 6.0 French

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

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

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

GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.