The following data is part of a premarket notification filed by Orbusneich Medical Trading Inc. with the FDA for Sapphire Ii Pro Balloon Dilatation Catheter.
| Device ID | K180921 |
| 510k Number | K180921 |
| Device Name: | Sapphire II PRO Balloon Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | OrbusNeich Medical Trading Inc. 5363 NW 35th Avenue Fort Lauderdale, FL 33060 |
| Contact | John Pazienza |
| Correspondent | John Pazienza OrbusNeich Medical Trading Inc. 5363 NW 35th Avenue Fort Lauderdale, FL 33060 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-09 |
| Decision Date | 2018-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06934955942150 | K180921 | 000 |
| 06934955942143 | K180921 | 000 |