The following data is part of a premarket notification filed by Vascular Solutions Llc with the FDA for R350 Guidewire, Spectre Guidewire, Raider Guidewire, Bandit Guidewire, Warrior Guidewire.
| Device ID | K212167 |
| 510k Number | K212167 |
| Device Name: | R350 Guidewire, Spectre Guidewire, Raider Guidewire, Bandit Guidewire, Warrior Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Vascular Solutions LLC 6464 Sycamore Court N Maple Grove, MN 55369 |
| Contact | Beka Vite |
| Correspondent | Beka Vite Vascular Solutions LLC 6464 Sycamore Court N Maple Grove, MN 55369 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-12 |
| Decision Date | 2022-02-09 |