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FDA 510(k)

ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip

K-Number: K171613 · 2017-07-01

ApplicantAsahi Intecc Co., Ltd.
Decision Date2017-07-01
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 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 2017-07-01 under 510(k) number K171613. 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 Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip?

ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip is a medical device that received FDA 510(k) clearance on 2017-07-01. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K171613.

When did ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip receive FDA 510(k) clearance?

ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip received FDA 510(k) clearance on 2017-07-01, under 510(k) number K171613.

Who is the listed applicant for ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 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 Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip?

The FDA product code for ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 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.

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