The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Fathom-16 Steerable Guidewires.
| Device ID | K170636 |
| 510k Number | K170636 |
| Device Name: | Fathom-16 Steerable Guidewires |
| Classification | Wire, Guide, Catheter |
| Applicant | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 |
| Contact | Keith Neligan |
| Correspondent | Keith Neligan Boston Scientific Corporation Three 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 | 2017-03-02 |
| Decision Date | 2017-03-22 |
| Summary: | summary |