ATHERECTOMY P4028 DS SILVERHAWK BTK UNI
SilverHawk™ - P4028
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
- Store in a cool dry place until ready to use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Device Sizes
- Effective Length: 132 CM
- Recommended Sheath Size: 6 F
- Max. Profile: 1.9 MM
- Max Guidewire: 0.36 MM
- Balloon Catheter Tip Length: 2.6 Centimeter
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: 00763000918910
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