AneuGuide— 510(k) K213838

Substantially Equivalent

ArteryFlow Technology Co., Ltd.

FDA 510(k) clearance K213838 for AneuGuide, Substantially Equivalent on 2022-06-01. Applicant: ArteryFlow Technology Co., Ltd..

Clearance details

Applicant: ArteryFlow Technology Co., Ltd.
Product code: Code PZO
Advisory panel: Radiology
Date received: 2021-12-09
Decision date: 2022-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou City, CN

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