The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai Rc Guidewire, Stretch Extension Wire.
| Device ID | K151840 |
| 510k Number | K151840 |
| Device Name: | Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 -1566 |
| Contact | Nikki M Wahlberg |
| Correspondent | Nikki M Wahlberg Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 -1566 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-06 |
| Decision Date | 2015-12-16 |
| Summary: | summary |