FDA 510(k)

Asahi PTCA Guide Wire Asahi SION Series

K-Number: K191464 · 2019-11-21

Decision Date2019-11-21

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Asahi PTCA Guide Wire Asahi SION Series 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 2019-11-21 under 510(k) number K191464. 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 PTCA Guide Wire Asahi SION Series?

Asahi PTCA Guide Wire Asahi SION Series is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K191464.

When did Asahi PTCA Guide Wire Asahi SION Series receive FDA 510(k) clearance?

Asahi PTCA Guide Wire Asahi SION Series received FDA 510(k) clearance on 2019-11-21, under 510(k) number K191464.

Who is the listed applicant for Asahi PTCA Guide Wire Asahi SION Series?

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 PTCA Guide Wire Asahi SION Series?

The FDA product code for Asahi PTCA Guide Wire Asahi SION Series 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.