Submission Details
| 510(k) Number | K212167 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 12, 2021 |
| Decision Date | February 09, 2022 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
Feb 2022
Decision
212d
Days
Class 2
Risk
About This 510(k) Submission
K212167 is an FDA 510(k) clearance for the R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Vascular Solutions, LLC (Maple Grove, US). The FDA issued a Cleared decision on February 9, 2022, 212 days after receiving the submission on July 12, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.
Device Classification
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1330 |
Manufacturer
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