The following data is part of a premarket notification filed by Orbusneich Medical Inc. with the FDA for Sapphire Ii Pro.
| Device ID | K163114 |
| 510k Number | K163114 |
| Device Name: | Sapphire II PRO |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | OrbusNeich Medical Inc. 5363 NW 35th Avenue Fort Lauderdale, FL 33309 |
| Contact | John Pazienza |
| Correspondent | John 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-07 |
| Decision Date | 2017-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06934955942457 | K163114 | 000 |
| 06934955942273 | K163114 | 000 |
| 06934955942266 | K163114 | 000 |
| 06934955942259 | K163114 | 000 |
| 06934955942242 | K163114 | 000 |
| 06934955942235 | K163114 | 000 |
| 06934955942228 | K163114 | 000 |
| 06934955942211 | K163114 | 000 |
| 06934955942204 | K163114 | 000 |
| 06934955942198 | K163114 | 000 |
| 06934955942181 | K163114 | 000 |
| 06934955942174 | K163114 | 000 |
| 06934955942167 | K163114 | 000 |
| 06934955942136 | K163114 | 000 |
| 06934955942129 | K163114 | 000 |
| 06934955942112 | K163114 | 000 |
| 06934955942280 | K163114 | 000 |
| 06934955942297 | K163114 | 000 |
| 06934955942440 | K163114 | 000 |
| 06934955942433 | K163114 | 000 |
| 06934955942426 | K163114 | 000 |
| 06934955942419 | K163114 | 000 |
| 06934955942402 | K163114 | 000 |
| 06934955942396 | K163114 | 000 |
| 06934955942389 | K163114 | 000 |
| 06934955942372 | K163114 | 000 |
| 06934955942365 | K163114 | 000 |
| 06934955942358 | K163114 | 000 |
| 06934955942341 | K163114 | 000 |
| 06934955942334 | K163114 | 000 |
| 06934955942327 | K163114 | 000 |
| 06934955942310 | K163114 | 000 |
| 06934955942303 | K163114 | 000 |
| 06934955942105 | K163114 | 000 |