Selethru(TM) NC PTCA Balloon Dilatation Catheter

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Kossel Medtech (Suzhou) Co., Ltd.

The following data is part of a premarket notification filed by Kossel Medtech (suzhou) Co., Ltd. with the FDA for Selethru(tm) Nc Ptca Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK211393
510k NumberK211393
Device Name:Selethru(TM) NC PTCA Balloon Dilatation Catheter
ClassificationCatheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant Kossel Medtech (Suzhou) Co., Ltd. F2-3, BLDG 6, No. 8, Jinfeng Road, Suzhou New District Suzhou,  CN 215163
ContactMaggie Xu
CorrespondentMaggie Xu
Kossel Medtech (Suzhou) Co., Ltd. F2-3, BLDG 6, No. 8, Jinfeng Road, Suzhou New District Suzhou,  CN 215163
Product CodeLOX  
CFR Regulation Number870.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-05
Decision Date2021-07-02

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