Pantheris A400

GUDID 00851354004370

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.

AVINGER, INC.

Mechanical atherectomy system, coronary/peripheral

• Primary Device ID: 00851354004370
• NIH Device Record Key: 1b1ce3de-cb35-4808-849f-193e9d5c46da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pantheris
• Version Model Number: A400
• Catalog Number: A400
• Company DUNS: 003152968
• Company Name: AVINGER, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 650-241-7030
• Email: tlawson@avinger.com
• Phone: 650-241-7030
• Email: tlawson@avinger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851354004370 [Primary]

FDA Product Code

• NQQ: System, Imaging, Optical Coherence Tomography (Oct)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00851354004370]

Radiation Sterilization

[00851354004370]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-29
• Device Publish Date: 2019-03-21

On-Brand Devices [Pantheris]

• 00851354004387: The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels
• 00851354004370: The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels