BrosMed Medical Co.,Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 8
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0963-2019 | Class II | Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate s | December 14, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; | February 27, 2025 |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | October 22, 2024 |
| K230705 | POT PTCA Balloon Dilatation Catheter | April 11, 2023 |
| K212215 | Tiche PTA Balloon Dilatation Catheter | July 19, 2022 |
| K203390 | Artimes pro Balloon Dilatation Catheter | April 14, 2021 |
| K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter | December 13, 2016 |
| K153742 | Apollo Balloon Dilatation Catheter | August 8, 2016 |
| K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter | July 29, 2016 |