Submission Details
| 510(k) Number | K180128 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 17, 2018 |
| Decision Date | February 16, 2018 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Warrior 14 guidewire
Feb 2018
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K180128 is an FDA 510(k) clearance for the Warrior 14 guidewire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on February 16, 2018, 30 days after receiving the submission on January 17, 2018. 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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