Hydrophilic Coating Guide Wire
K-Number: K193653 · 2020-08-26
Decision Date2020-08-26
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Hydrophilic Coating Guide Wire is a medical device manufactured by Suzhou Hengrui Disheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-08-26 under approval 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. It is manufactured by Suzhou Hengrui Disheng Medical Co., Ltd.. The 510(k) number is K193653.
When was Hydrophilic Coating Guide Wire approved by the FDA?
Hydrophilic Coating Guide Wire received FDA 510(k) clearance on 2020-08-26, under approval number K193653.
What company makes Hydrophilic Coating Guide Wire?
Hydrophilic Coating Guide Wire is manufactured by Suzhou Hengrui Disheng Medical Co., Ltd..
What is the FDA product code for Hydrophilic Coating Guide Wire?
The FDA product code for Hydrophilic Coating Guide Wire 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.