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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