Orbusneich Medical Trading, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200269 | Sapphire II PRO | March 4, 2020 |
| K192344 | Sapphire NC Plus Coronary Dilatation Catheter | September 19, 2019 |
| K182713 | Scoreflex PTA Scoring Balloon Catheter | June 11, 2019 |
| K182360 | Teleport Microcatheter | November 9, 2018 |
| K180921 | Sapphire II PRO Balloon Dilatation Catheter | June 28, 2018 |
| K173680 | Sapphire II PRO | March 1, 2018 |
| K173894 | Jade PTA Balloon Dilatation Catheter | February 9, 2018 |