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 a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2020-01-02 under approval 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. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K192599.
When was ASAHI PTCA Guide Wire ASAHI Gaia Next approved by the FDA?
ASAHI PTCA Guide Wire ASAHI Gaia Next received FDA 510(k) clearance on 2020-01-02, under approval number K192599.
What company makes ASAHI PTCA Guide Wire ASAHI Gaia Next?
ASAHI PTCA Guide Wire ASAHI Gaia Next is manufactured by Asahi Intecc Co., Ltd..
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.