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FDA 510(k)

Inno-Hydrowire

K-Number: K172187 · 2018-04-11

ApplicantSuzhou Innomed Medical Device Co., Ltd.
Decision Date2018-04-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Inno-Hydrowire is a medical device manufactured by Suzhou Innomed Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2018-04-11 under approval number K172187. 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 Inno-Hydrowire?

Inno-Hydrowire is a medical device that received FDA 510(k) clearance on 2018-04-11. It is manufactured by Suzhou Innomed Medical Device Co., Ltd.. The 510(k) number is K172187.

When was Inno-Hydrowire approved by the FDA?

Inno-Hydrowire received FDA 510(k) clearance on 2018-04-11, under approval number K172187.

What company makes Inno-Hydrowire?

Inno-Hydrowire is manufactured by Suzhou Innomed Medical Device Co., Ltd..

What is the FDA product code for Inno-Hydrowire?

The FDA product code for Inno-Hydrowire is DQX.

Other Devices by Suzhou Innomed Medical Device Co., Ltd.

K182553Inno-Pathwire

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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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