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. |
| K241478 |
05/24/2024 |
Tri-Wedge PTA Scoring Balloon Dilatation Catheter |
BrosMed Medical Co., Ltd. |
| K212215 |
07/15/2021 |
Tiche PTA Balloon Dilatation Catheter |
BrosMed Medical Co., Ltd. |
| K243704 |
11/29/2024 |
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 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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