The following data is part of a premarket notification filed by Orbusneich Medical Trading Inc. with the FDA for Sapphire Ii Pro.
| Device ID | K200269 |
| 510k Number | K200269 |
| Device Name: | Sapphire II PRO |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | OrbusNeich Medical Trading Inc. 5363 NW 35th Avenue Fort Lauderdale, FL 33309 |
| Contact | John Pazienza |
| Correspondent | John Pazienza OrbusNeich Medical Trading Inc. 5363 NW 35th Avenue Fort Lauderdale, FL 33309 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-04 |
| Decision Date | 2020-03-04 |