AneuGuide
K-Number: K213838 · 2022-06-01
ApplicantArteryFlow Technology Co., Ltd.
Decision Date2022-06-01
Product CodePZO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
AneuGuide is a medical device manufactured by ArteryFlow Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-01 under approval 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. It is manufactured by ArteryFlow Technology Co., Ltd.. The 510(k) number is K213838.
When was AneuGuide approved by the FDA?
AneuGuide received FDA 510(k) clearance on 2022-06-01, under approval number K213838.
What company makes AneuGuide?
AneuGuide is manufactured by ArteryFlow Technology Co., Ltd..
What is the FDA product code for AneuGuide?
The FDA product code for AneuGuide is PZO.
Other Devices by ArteryFlow Technology Co., Ltd.
Related Devices (Code: PZO)
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.