OptiCross™ 18 Peripheral Imaging Catheter
Catheter, Ultrasound, Intravascular
Boston Scientific Corporation
The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Opticross™ 18 Peripheral Imaging Catheter.
Pre-market Notification Details
| Device ID | K222568 |
| 510k Number | K222568 |
| Device Name: | OptiCross™ 18 Peripheral Imaging Catheter |
| 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 | 2022-08-24 |
| Decision Date | 2022-09-23 |
Trademark Results [OptiCross]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTICROSS 85718478 4619353 Live/Registered |
Boston Scientific Scimed, Inc. 2012-08-31 |
 OPTICROSS 79110412 not registered Dead/Abandoned |
Hitachi High-Technologies Corporation 2012-02-01 |
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