The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Opticross X, 40 Mhz Coronary Imaging Catheter.
| Device ID | K161125 |
| 510k Number | K161125 |
| Device Name: | OptiCross X, 40 MHz Coronary Imaging Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Boston Scientific Corporation 47215 Lakeview Boulevard Fremont, CA 94538 |
| Contact | Eric Elliott |
| Correspondent | Eric Elliott Boston Scientific Corporation 47215 Lakeview Boulevard Fremont, CA 94538 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-21 |
| Decision Date | 2016-05-19 |
| Summary: | summary |