The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Spectre Guidewire.
| Device ID | K163444 |
| 510k Number | K163444 |
| Device Name: | Spectre Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Beka Vite |
| Correspondent | Beka Vite Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-08 |
| Decision Date | 2017-01-06 |
| Summary: | summary |