OrbusNeich Medical (Shenzhen) Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | January 7, 2025 |
| K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | August 16, 2024 |
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | August 15, 2024 |
| K241025 | JADE PLUS PTA Balloon Dilatation Catheter | June 11, 2024 |
| K231608 | Teleport XT Microcatheter | January 7, 2024 |
| K211807 | Sapphire NC 24 | October 14, 2021 |
| K202231 | JADE | December 10, 2020 |
| K201794 | Jade | July 28, 2020 |