The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Opticross, Opticross Hd, Opticross 6, Opticross 6 Hd.
| Device ID | K213593 |
| 510k Number | K213593 |
| Device Name: | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Boston Scientific Corporation 1 Scimed Place Maple Grove, MN 55311 |
| Contact | Cassie Clark |
| Correspondent | Cassie Clark Boston Scientific Corporation 1 Scimed Place Maple Grove, MN 55311 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-12 |
| Decision Date | 2022-01-14 |