The following data is part of a premarket notification filed by Orbusneich Medical, Inc. with the FDA for Sapphire Nc.
| Device ID | K103808 |
| 510k Number | K103808 |
| Device Name: | SAPPHIRE NC |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ORBUSNEICH MEDICAL, INC. 5363 N.W. 35TH AVE. Ft. Lauderdale, FL 33309 -6315 |
| Contact | John Pazienza |
| Correspondent | John Pazienza ORBUSNEICH MEDICAL, INC. 5363 N.W. 35TH AVE. Ft. Lauderdale, FL 33309 -6315 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-29 |
| Decision Date | 2011-09-01 |
| Summary: | summary |