K151825 is an FDA 510(k) clearance for the Viradius Neurowire. This device is classified as a Guide, Wire, Catheter, Neurovasculature (Class II - Special Controls, product code MOF).
Submitted by Mivi Neuroscience, Inc. (Eden Prarie, US). The FDA issued a Cleared decision on November 16, 2015, 133 days after receiving the submission on July 6, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K151825 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2015 |
| Decision Date | November 16, 2015 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MOF - Guide, Wire, Catheter, Neurovasculature |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |