FDA 510(k)

ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010

K-Number: K183070 · 2019-01-29

Decision Date2019-01-29

Product CodeMOF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 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 2019-01-29 under 510(k) 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. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K183070.

When did ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 receive FDA 510(k) clearance?

ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 received FDA 510(k) clearance on 2019-01-29, under 510(k) number K183070.

Who is the listed applicant for ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010?

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 Neurovascular Guide Wire, ASAHI CHIKAI X 010?

The FDA product code for ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 is MOF.

Other records listing Asahi Intecc Co., Ltd. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.