Submission Details
| 510(k) Number | K151234 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 08, 2015 |
| Decision Date | November 18, 2015 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
R350 guidewire
Nov 2015
Decision
194d
Days
Class 2
Risk
About This 510(k) Submission
K151234 is an FDA 510(k) clearance for the R350 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 November 18, 2015, 194 days after receiving the submission on May 8, 2015. 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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