The following data is part of a premarket notification filed by Orbusneich Medical, Inc with the FDA for Sapphire Nc Plus.
| Device ID | K162209 |
| 510k Number | K162209 |
| Device Name: | Sapphire NC Plus |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | OrbusNeich Medical, Inc 5363 NW 35th Avenue Fort Lauderdale, FL 33309 |
| Contact | John D. Pazienza |
| Correspondent | John D. Pazienza OrbusNeich Medical, 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 | 2016-08-05 |
| Decision Date | 2016-10-06 |
| Summary: | summary |