Pantheris

Basic Information

• Brand Name: Pantheris
• Primary DI: 00851354004387
• Version / Model: A400X
• Catalog Number: A400X
• Company Name: AVINGER, INC.
• Labeler DUNS: 003152968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-21
• Public Version: 1
• Public Version Date: 2019-03-29
• Public Version Status: New
• Public Device Record Key: bb140215-ae4c-4b90-a970-b8a4082a29e5

Device Description

The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	892.1560	2
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	870.4875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46850	Mechanical atherectomy system, coronary/peripheral	An assembly of devices intended to mechanically disrupt/remove atheroma plaque from the walls of both coronary and peripheral arteries. It typically includes a mains electricity (AC-powered) energy-producing generator with monitoring functions, a remote control or foot-switch, a handpiece (to which the catheter connects) and a dedicated disposable catheter with a cutting or abrasive head that transmits the mechanical energy to the atheroma. The system may include an integrated irrigation/suction system includes/requires accessory devices for its function (e.g., saline/lubricant, pump, guidewire).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851354004387	GS1

Customer Contacts

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