The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Opticross 18, 30 Mhz Peripheral Imaging Catheter.
| Device ID | K160514 |
| 510k Number | K160514 |
| Device Name: | OptiCross 18, 30 MHz Peripheral Imaging Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | BOSTON SCIENTIFIC CORPORATION 47215 LAKEVIEW BLVD Fremont, CA 94538 |
| Contact | Eric Elliott |
| Correspondent | Eric Elliott BOSTON SCIENTIFIC CORPORATION 47215 LAKEVIEW BLVD Fremont, CA 94538 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-24 |
| Decision Date | 2016-06-22 |
| Summary: | summary |