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 the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2019-07-01 under 510(k) 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. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K183062.

When did ASAHI Silverway receive FDA 510(k) clearance?

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

Who is the listed applicant for ASAHI Silverway?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASAHI Silverway?

The FDA product code for ASAHI Silverway is DQX.

Other records listing Asahi Intecc Co., Ltd. as applicant

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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.