Directional Atherectomy System, Large Vessel Extended Tip

Directional Atherectomy System, Large Vessel Extended Tip
HawkOne - H1-LX

A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.

• Recommended Sheath,7,FR;Vessel Range,3.5-7.0,MM;Maximum Profile,2.6,MM;Compatible Guidewire,0.014,IN;Effective Length,104,CM;Tip Length,9.6,CM

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: 00821684057933

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