Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AneuGuide

K-Number: K213838 · 2022-06-01

Decision Date2022-06-01
Product CodePZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AneuGuide is the device name listed in this FDA 510(k) record. The listed applicant is ArteryFlow Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-01 under 510(k) number K213838. The device is classified under product code PZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AneuGuide?

AneuGuide is a medical device that received FDA 510(k) clearance on 2022-06-01. The listed applicant is ArteryFlow Technology Co., Ltd.. The 510(k) number is K213838.

When did AneuGuide receive FDA 510(k) clearance?

AneuGuide received FDA 510(k) clearance on 2022-06-01, under 510(k) number K213838.

Who is the listed applicant for AneuGuide?

The FDA 510(k) record lists ArteryFlow Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AneuGuide?

The FDA product code for AneuGuide is PZO.

Other records listing ArteryFlow Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: PZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.