FDA 510(k)

ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip

K-Number: K171613 · 2017-07-01

Decision Date2017-07-01

Product CodeMOF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

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

When was ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip approved by the FDA?

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

What company makes ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip?

ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip is manufactured by Asahi Intecc Co., Ltd..

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

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