FDA 510(k) Applications Submitted by Brosmed Medical Co., Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K230705 03/14/2023 POT PTCA Balloon Dilatation Catheter BrosMed Medical Co., Ltd.
K212215 07/15/2021 Tiche PTA Balloon Dilatation Catheter BrosMed Medical Co., Ltd.
K160256 02/01/2016 Polux , Minerva and Atropos PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd.
K160941 04/04/2016 Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd.
K153742 12/28/2015 Apollo Balloon Dilatation Catheter BrosMed Medical Co., Ltd.
K203390 11/18/2020 Artimes pro Balloon Dilatation Catheter BrosMed Medical Co., Ltd.


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