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

FDA 510(k)

AccuFFRangio

K-Number: K210093 · 2021-09-10

ApplicantArteryFlow Technology Co., Ltd.
Decision Date2021-09-10
Product CodeQHA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AccuFFRangio is a medical device manufactured by ArteryFlow Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-10 under approval number K210093. The device is classified under product code QHA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AccuFFRangio?

AccuFFRangio is a medical device that received FDA 510(k) clearance on 2021-09-10. It is manufactured by ArteryFlow Technology Co., Ltd.. The 510(k) number is K210093.

When was AccuFFRangio approved by the FDA?

AccuFFRangio received FDA 510(k) clearance on 2021-09-10, under approval number K210093.

What company makes AccuFFRangio?

AccuFFRangio is manufactured by ArteryFlow Technology Co., Ltd..

What is the FDA product code for AccuFFRangio?

The FDA product code for AccuFFRangio is QHA.

Other Devices by ArteryFlow Technology Co., Ltd.

K220663AccuCTP K213838AneuGuide K231353AccuCTP Pro K230303AccuFFRangio Plus K221711AccuICAS

Related Devices (Code: QHA)

K182611Qangio XA 3DMedis Medical Imaging Systems BV K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd. K221711AccuICASArteryFlow Technology Co., Ltd. K232147CAAS WorkstationPie Medical Imaging BV K251355X1-FFRSpectrawave, Inc. K243769QFR (3.0)Qfr Solutions BV

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.

↑