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Pantheris

FDA UDI

Class II (US FDA UDI)

by Avinger, Inc.

Identity

Trade Name
Pantheris FDA UDI
Generic Name
Mechanical atherectomy system, coronary/peripheral FDA UDI
Device Name
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. FDA UDI
Model / Reference
A400X FDA UDI
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. FDA UDI

Identifiers

Catalog Number
A400X FDA UDI
Primary DI / UDI-DI
00851354004387 FDA UDI
FDA Product Code
NQQ FDA UDI
MCW FDA UDI
GMDN Term
Mechanical atherectomy system, coronary/peripheral FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
870.4875 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Mechanical atherectomy system, coronary/peripheral

Pantheris by Avinger, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical atherectomy system, coronary/peripheral.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avinger, Inc.

Sources (1)

  • FDA UDI bb140215-ae4c-4b90-a970-b8a4082a29e5 35 fields · synced Jun 8, 2026