ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
K-Number: K161912 · 2016-10-14
ApplicantAsahi Intecc Co., Ltd.
Decision Date2016-10-14
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2016-10-14 under approval number K161912. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip is a medical device that received FDA 510(k) clearance on 2016-10-14. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K161912.
When was ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip approved by the FDA?
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip received FDA 510(k) clearance on 2016-10-14, under approval number K161912.
What company makes ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip is manufactured by Asahi Intecc Co., Ltd..
What is the FDA product code for ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?
The FDA product code for ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip is MOF.
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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.