Artimes Pro Balloon Dilatation Catheter

Catheters, Transluminal Coronary Angioplasty, Percutaneous

BrosMed Medical Co., Ltd.

The following data is part of a premarket notification filed by Brosmed Medical Co., Ltd. with the FDA for Artimes Pro Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK203390
510k NumberK203390
Device Name:Artimes Pro Balloon Dilatation Catheter
ClassificationCatheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant BrosMed Medical Co., Ltd. 15th Building, SMEs Venture Park, Songshan Lake Hi-Tech Development Zone Dongguan,  CN 523808
ContactWade Zhang
CorrespondentDiane Horwitz
Eminence Clinical Research Inc. 5 Lake Como Ct. Greenville,  SC  29609
Product CodeLOX  
CFR Regulation Number870.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-18
Decision Date2021-04-14

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