Hydrophilic Coating Guide Wire

Wire, Guide, Catheter

Suzhou Hengrui Disheng Medical Co.,Ltd.

The following data is part of a premarket notification filed by Suzhou Hengrui Disheng Medical Co.,ltd. with the FDA for Hydrophilic Coating Guide Wire.

Pre-market Notification Details

Device IDK193653
510k NumberK193653
Device Name:Hydrophilic Coating Guide Wire
ClassificationWire, Guide, Catheter
Applicant Suzhou Hengrui Disheng Medical Co.,Ltd. No. 11 Building, No.8 Jinfeng Road Suzhou 215163,  CN 215163
ContactLing Li
CorrespondentLing Li
Suzhou Hengrui Disheng Medical Co.,Ltd. No. 11 Building, No.8 Jinfeng Road Suzhou 215163,  CN 215163
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-30
Decision Date2020-08-26

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