FDA 510(k)

ASAHI Silverway

K-Number: K183062 · 2019-07-01

Decision Date2019-07-01

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI Silverway is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2019-07-01 under approval number K183062. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI Silverway?

ASAHI Silverway is a medical device that received FDA 510(k) clearance on 2019-07-01. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K183062.

When was ASAHI Silverway approved by the FDA?

ASAHI Silverway received FDA 510(k) clearance on 2019-07-01, under approval number K183062.

What company makes ASAHI Silverway?

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

What is the FDA product code for ASAHI Silverway?

The FDA product code for ASAHI Silverway is DQX.

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.