The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Opticross 6, 40 Mhz Coronary Imaging Catheter (us Distribution), Opticross 6, 40 Mhz Coronary Imaging Catheter (eu Distribution), Opticross 6, 40 Mhz Coronary Imaging Catheter (intercontinental Distribution).
| Device ID | K153617 |
| 510k Number | K153617 |
| Device Name: | OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-18 |
| Decision Date | 2016-02-25 |
| Summary: | summary |