OrbusNeich Medical (Shenzhen) Co., Ltd.
FDA 510(k) & PMA Approved Devices — 10 products
Total Devices10
Categories4
Latest FDA decision2026-07-31
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P200041 | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring | NWX | 2026-07-31 | View |
| 510(k) | K253361 | Teleport Glide Microcatheter | DQY | 2026-04-10 | View |
| 510(k) | K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | DQY | 2025-01-07 | View |
| 510(k) | K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | LOX | 2024-08-16 | View |
| 510(k) | K233505 | Sapphire ULTRA Coronary Dilatation Catheter | LOX | 2024-08-15 | View |
| 510(k) | K241025 | JADE PLUS PTA Balloon Dilatation Catheter | LIT | 2024-06-11 | View |
| 510(k) | K231608 | Teleport XT Microcatheter | DQY | 2024-01-07 | View |
| 510(k) | K211807 | Sapphire NC 24 | LOX | 2021-10-14 | View |
| 510(k) | K202231 | JADE | LIT | 2020-12-10 | View |
| 510(k) | K201794 | Jade | LIT | 2020-07-28 | View |
No matching devices.