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FDA 510(k) Applications Submitted by Kossel Medtech (Suzhou) Co., Ltd.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K211393
05/05/2021
Selethru(TM) NC PTCA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd.
K221245
05/02/2022
PTA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd.
K211349
05/03/2021
Selebrek PTCA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd.
K182699
09/27/2018
Selethru PTCA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd.
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