FDA 510(k)

ASAHI SASUKE

K-Number: K182844 · 2019-06-22

Decision Date2019-06-22

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI SASUKE is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2019-06-22 under approval number K182844. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI SASUKE?

ASAHI SASUKE is a medical device that received FDA 510(k) clearance on 2019-06-22. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K182844.

When was ASAHI SASUKE approved by the FDA?

ASAHI SASUKE received FDA 510(k) clearance on 2019-06-22, under approval number K182844.

What company makes ASAHI SASUKE?

ASAHI SASUKE is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for ASAHI SASUKE?

The FDA product code for ASAHI SASUKE is DQY.

Other Devices by Asahi Intecc Co., Ltd.

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Official Source

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