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AneuGuide

by ArteryFlow Technology Co., Ltd. 510(k)

Active United States

510(k) K213838

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213838 Date1 Jun 2022ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
PZO
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from ArteryFlow Technology Co., Ltd.

  • AccuCTP

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  • AccuICAS

    Class II

  • AccuFFRangio

    Class II

  • AccuFFRangio Plus

    Class II

  • AccuCTP Pro

    Class II