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 ID00851354004370
NIH Device Record Key1b1ce3de-cb35-4808-849f-193e9d5c46da
Commercial Distribution StatusIn Commercial Distribution
Brand NamePantheris
Version Model NumberA400
Catalog NumberA400
Company DUNS003152968
Company NameAVINGER, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-241-7030
Emailtlawson@avinger.com
Phone650-241-7030
Emailtlawson@avinger.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851354004370 [Primary]

FDA Product Code

NQQSystem, Imaging, Optical Coherence Tomography (Oct)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00851354004370]

Radiation Sterilization


[00851354004370]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-29
Device Publish Date2019-03-21

On-Brand Devices [Pantheris]

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

Trademark Results [Pantheris]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PANTHERIS
PANTHERIS
85863579 4837148 Live/Registered
Avinger, Inc.
2013-02-28

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