Asahi PTCA Guide Wire Asahi SION Series
K-Number: K191464 · 2019-11-21
ApplicantAsahi Intecc Co., Ltd.
Decision Date2019-11-21
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Asahi PTCA Guide Wire Asahi SION Series is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2019-11-21 under approval 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. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K191464.
When was Asahi PTCA Guide Wire Asahi SION Series approved by the FDA?
Asahi PTCA Guide Wire Asahi SION Series received FDA 510(k) clearance on 2019-11-21, under approval number K191464.
What company makes Asahi PTCA Guide Wire Asahi SION Series?
Asahi PTCA Guide Wire Asahi SION Series is manufactured by Asahi Intecc Co., Ltd..
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.
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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.