The following data is part of a premarket notification filed by Boston Scientific with the FDA for Ekos+ Endovascular Device.
| Device ID | K220866 |
| 510k Number | K220866 |
| Device Name: | EKOS+ Endovascular Device |
| Classification | Mechanical Thrombolysis Catheter |
| Applicant | Boston Scientific Two Scimed Place Maple Grove, MN 55311 |
| Contact | Daniel Root |
| Correspondent | Daniel Root Boston Scientific Two Scimed Place Maple Grove, MN 55311 |
| Product Code | QEY |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-25 |
| Decision Date | 2022-04-20 |