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FDA 510(k)

AccuCTP Pro

K-Number: K231353 · 2023-09-14

ApplicantArteryFlow Technology Co., Ltd.
Decision Date2023-09-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AccuCTP Pro is a medical device manufactured by ArteryFlow Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-14 under approval number K231353. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AccuCTP Pro?

AccuCTP Pro is a medical device that received FDA 510(k) clearance on 2023-09-14. It is manufactured by ArteryFlow Technology Co., Ltd.. The 510(k) number is K231353.

When was AccuCTP Pro approved by the FDA?

AccuCTP Pro received FDA 510(k) clearance on 2023-09-14, under approval number K231353.

What company makes AccuCTP Pro?

AccuCTP Pro is manufactured by ArteryFlow Technology Co., Ltd..

What is the FDA product code for AccuCTP Pro?

The FDA product code for AccuCTP Pro is LLZ.

Other Devices by ArteryFlow Technology Co., Ltd.

K210093AccuFFRangio K220663AccuCTP K213838AneuGuide K230303AccuFFRangio Plus K221711AccuICAS

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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.

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