The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire.
| Device ID | K152231 |
| 510k Number | K152231 |
| Device Name: | Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | BOSTON SCIENTIFIC CORPORATION One Scimed Place Maple Grove, MN 55311 |
| Contact | Nikki M Wahlberg |
| Correspondent | Nikki M Wahlberg BOSTON SCIENTIFIC CORPORATION One Scimed Place Maple Grove, MN 55311 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-07 |
| Decision Date | 2016-02-12 |
| Summary: | summary |