ATHERECTOMY THP
TurboHawk™ Plus - THP-LS
Device Description
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.
Environmental Conditions
- Keep dry
- Keep away from sunlight
- Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
- 60.00
- -29.00
Device Sizes
- Catheter Gauge: 7.0 French
- Compatible guidewire 0.36MM
- Length: 107.0 Centimeter
- Balloon Diameter: 2.6 Millimeter
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 IdentifiersDevice Id: 00763000402372
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