TurboHawk™ Plus

Basic Information

• Brand Name: TurboHawk™ Plus
• Primary DI: 00763000402396
• Version / Model: THP-M
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-26
• Public Version: 1
• Public Version Date: 2021-10-04
• Public Version Status: New
• Public Device Record Key: a8e1369d-e930-47c4-9c35-896857e35de6

Device Description

ATHERECTOMY THP-M TH PLUS 6F US

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCW	Catheter, peripheral, atherectomy	Cardiovascular	870.4875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44307	Mechanical atherectomy system catheter, peripheral	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000402396	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K212027	000

Device Sizes

Type	Value	Unit	Text
Balloon Diameter	2.2	Millimeter
Device Size Text, specify			Compatible guidewire 0.36MM
Catheter Gauge	6.0	French
Length	129.0	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Type: Storage Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry