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Pantheris A400X

by Avinger, Inc.

Pantheris A400X is a Class II device made by Avinger, Inc., listed in FDA GUDID since 21 Mar 2019 (UDI-DI 00851354004387), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851354004387 UDI-DI Date21 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Pantheris
Generic name
Mechanical atherectomy system, coronary/peripheral
Model / Ref / Catalog
A400X
Primary DI / UDI-DI
00851354004387
FDA product code
NQQ, MCW
GMDN term
Mechanical atherectomy system, coronary/peripheral
Device class
Class II
Regulation number
892.1560, 870.4875
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Related devices

Category: Mechanical atherectomy system, coronary/peripheral

Similar devices

Also classified as Mechanical atherectomy system, coronary/peripheral.

Similar devices

Other devices filed under FDA product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)).

Other devices from Avinger, Inc.

See all devices from Avinger, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (6, all answered No)