The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Opticross Hd, 60 Mhz Coronary Imaging Catheter (paper Dfu); Opticross Hd, 60 Mhz Coronary Imaging Catheter (e-dfu).
| Device ID | K173284 |
| 510k Number | K173284 |
| Device Name: | OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Boston Scientific Corporation 47215 Lakeview Boulevard Fremont, CA 94538 |
| Contact | Mugdha Dongre |
| Correspondent | Mugdha Dongre 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 | 2017-10-16 |
| Decision Date | 2017-11-16 |
| Summary: | summary |