The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Magic Torque Dlvr Guidewire.
| Device ID | K182315 |
| 510k Number | K182315 |
| Device Name: | Magic Torque DLVR Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Boston Scientific Corporation 3 Scimed Place Maple Grove, MN 55311 |
| Contact | Andrea Dance |
| Correspondent | Andrea Dance Boston Scientific Corporation 3 Scimed Place Maple Grove, MN 55311 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-27 |
| Decision Date | 2018-09-26 |
| Summary: | summary |