ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
K-Number: K183070 · 2019-01-29
ApplicantAsahi Intecc Co., Ltd.
Decision Date2019-01-29
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2019-01-29 under approval number K183070. 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 X 010?
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 is a medical device that received FDA 510(k) clearance on 2019-01-29. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K183070.
When was ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 approved by the FDA?
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 received FDA 510(k) clearance on 2019-01-29, under approval number K183070.
What company makes ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010?
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 is manufactured by Asahi Intecc Co., Ltd..
What is the FDA product code for ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010?
The FDA product code for ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 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.