- Physicians Office Resource

JETSTREAM XC 2.4MM, FG PKG
JETSTREAM XC - 112266-001

Device Description

A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of atheroma and clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing acute to chronic vascular obstruction in native and stented blood vessels, native and synthetic bypass, or haemodialysis access grafts, through a mechanical rotational action intended to shatter/erode the obstruction and aspirate debris for collection. It typically consists of a catheter with a rotating head with a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile covers and collecting bags may be included. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

Catheter Gauge: 7 French

Catheter Gauge: 7 French

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: MCW

Device Name: Catheter, Peripheral, Atherectomy

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: 870.4875

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 00616258005157

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.