Selebrek 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 Selebrek Ptca Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK211349
510k NumberK211349
Device Name:Selebrek PTCA Balloon Dilatation Catheter
ClassificationCatheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant Kossel Medtech (Suzhou) Co., Ltd. F2-F3, BLDG 6, No. 8, Jinfeng Road Suzhou,  CN 215163
ContactZane Wang
CorrespondentZane Wang
Kossel Medtech (Suzhou) Co., Ltd. F2-F3, BLDG 6, No. 8, Jinfeng Road Suzhou,  CN 215163
Product CodeLOX  
CFR Regulation Number870.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-03
Decision Date2022-01-07

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