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FDA 510(k)

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 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 2016-10-14 under 510(k) 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. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K161912.

When did ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip receive FDA 510(k) clearance?

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161912.

Who is the listed applicant for ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?

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 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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Related Devices (Code: MOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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