FDA 510(k)

ASAHI GUIDE WIRE EXTENSION 165CM

K-Number: K101985 · 2011-03-07

Decision Date2011-03-07

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI GUIDE WIRE EXTENSION 165CM 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 2011-03-07 under 510(k) number K101985. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI GUIDE WIRE EXTENSION 165CM?

ASAHI GUIDE WIRE EXTENSION 165CM is a medical device that received FDA 510(k) clearance on 2011-03-07. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K101985.

When did ASAHI GUIDE WIRE EXTENSION 165CM receive FDA 510(k) clearance?

ASAHI GUIDE WIRE EXTENSION 165CM received FDA 510(k) clearance on 2011-03-07, under 510(k) number K101985.

Who is the listed applicant for ASAHI GUIDE WIRE EXTENSION 165CM?

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 GUIDE WIRE EXTENSION 165CM?

The FDA product code for ASAHI GUIDE WIRE EXTENSION 165CM is DQX.

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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.