Matreneu Percutaneous Balloon Compression Kit

Instrument, Surgical, Non-powered

Shenzhen Shineyard Medical Device Co. Ltd.

The following data is part of a premarket notification filed by Shenzhen Shineyard Medical Device Co. Ltd. with the FDA for Matreneu Percutaneous Balloon Compression Kit.

Pre-market Notification Details

Device IDK220920
510k NumberK220920
Device Name:Matreneu Percutaneous Balloon Compression Kit
ClassificationInstrument, Surgical, Non-powered
Applicant Shenzhen Shineyard Medical Device Co. Ltd. 3F, Changfeng Industrial Block No.3 Liuxian Road, Xin’an Bao’an District, Shenzhen,  CN 518000
ContactYan Ping
CorrespondentJoyce Yang
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen,  CN 518100
Product CodeHAO  
CFR Regulation Number882.4535 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-30
Decision Date2022-09-07

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