HRSpheres Narrow-Size Embolic Microspheres

Device, Vascular, For Promoting Embolization

Suzhou Hengrui Hongyuan Medical Co., Ltd.

The following data is part of a premarket notification filed by Suzhou Hengrui Hongyuan Medical Co., Ltd. with the FDA for Hrspheres Narrow-size Embolic Microspheres.

Pre-market Notification Details

Device IDK210562
510k NumberK210562
Device Name:HRSpheres Narrow-Size Embolic Microspheres
ClassificationDevice, Vascular, For Promoting Embolization
Applicant Suzhou Hengrui Hongyuan Medical Co., Ltd. Building B9 Unit 201, No. 218 Xinghu Road, SIP, Suzhou,  CN 215123
ContactQianqian Zhang
CorrespondentQianqian Zhang
Suzhou Hengrui Hongyuan Medical Co., Ltd. Building B9 Unit 201, No. 218 Xinghu Road, SIP, Suzhou,  CN 215123
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-25
Decision Date2021-10-01

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