Orbusneich Medical Trading, Inc.
FDA 510(k) & PMA Approved Devices — 7 products
Total Devices7
Categories4
Latest FDA decision2020-03-04
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K200269 | Sapphire II PRO | LOX | 2020-03-04 | View |
| 510(k) | K192344 | Sapphire NC Plus Coronary Dilatation Catheter | LOX | 2019-09-19 | View |
| 510(k) | K182713 | Scoreflex PTA Scoring Balloon Catheter | PNO | 2019-06-11 | View |
| 510(k) | K182360 | Teleport Microcatheter | DQY | 2018-11-09 | View |
| 510(k) | K180921 | Sapphire II PRO Balloon Dilatation Catheter | LOX | 2018-06-28 | View |
| 510(k) | K173680 | Sapphire II PRO | LOX | 2018-03-01 | View |
| 510(k) | K173894 | Jade PTA Balloon Dilatation Catheter | LIT | 2018-02-09 | View |
No matching devices.