The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Zelantedvt Thrombectomy Set.
| Device ID | K151313 |
| 510k Number | K151313 |
| Device Name: | ZelanteDVT Thrombectomy Set |
| Classification | Catheter, Embolectomy |
| Applicant | BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Anne V. Rossi |
| Correspondent | Anne V. Rossi BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2015-09-21 |
| Summary: | summary |