JETSTREAM XC 2.4MM, FG PKG

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

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.

No Data Available

• Catheter Gauge: 7 French

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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