FDA 510(k)

Hydrophilic Coating Guide Wire

K-Number: K193653 · 2020-08-26

ApplicantSuzhou Hengrui Disheng Medical Co., Ltd.

Decision Date2020-08-26

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Hydrophilic Coating Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Hengrui Disheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K193653. 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 Hydrophilic Coating Guide Wire?

Hydrophilic Coating Guide Wire is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Suzhou Hengrui Disheng Medical Co., Ltd.. The 510(k) number is K193653.

When did Hydrophilic Coating Guide Wire receive FDA 510(k) clearance?

Hydrophilic Coating Guide Wire received FDA 510(k) clearance on 2020-08-26, under 510(k) number K193653.

Who is the listed applicant for Hydrophilic Coating Guide Wire?

The FDA 510(k) record lists Suzhou Hengrui Disheng Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hydrophilic Coating Guide Wire?

The FDA product code for Hydrophilic Coating Guide Wire is DQX.

Other records listing Suzhou Hengrui Disheng Medical Co., Ltd. as applicant

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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.