Submission Details
| 510(k) Number | K181647 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 22, 2018 |
| Decision Date | July 20, 2018 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Bandit guidewire
Jul 2018
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K181647 is an FDA 510(k) clearance for the Bandit 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 July 20, 2018, 28 days after receiving the submission on June 22, 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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