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FDA 510(k)

ASAHI PTCA Guide Wire ASAHI Gaia Next

K-Number: K192599 · 2020-01-02

ApplicantAsahi Intecc Co., Ltd.
Decision Date2020-01-02
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI PTCA Guide Wire ASAHI Gaia Next 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 2020-01-02 under 510(k) number K192599. 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 Gaia Next?

ASAHI PTCA Guide Wire ASAHI Gaia Next is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K192599.

When did ASAHI PTCA Guide Wire ASAHI Gaia Next receive FDA 510(k) clearance?

ASAHI PTCA Guide Wire ASAHI Gaia Next received FDA 510(k) clearance on 2020-01-02, under 510(k) number K192599.

Who is the listed applicant for ASAHI PTCA Guide Wire ASAHI Gaia Next?

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 Gaia Next?

The FDA product code for ASAHI PTCA Guide Wire ASAHI Gaia Next is DQX.

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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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