The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Zelantedvt Thrombectomy System, Zelantedvt Clothunter Helical Rotation Device.
| Device ID | K202218 |
| 510k Number | K202218 |
| Device Name: | ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| Applicant | Boston Scientific Corporation 3 Scimed Place Maple Grove, MN 55311 |
| Contact | Vanessa Fowler |
| Correspondent | Vanessa Fowler Boston Scientific Corporation 3 Scimed Place Maple Grove, MN 55311 |
| Product Code | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-06 |
| Decision Date | 2020-10-02 |