K181828 is an FDA 510(k) clearance for the Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile. This device is classified as a Guide, Wire, Catheter, Neurovasculature (Class II - Special Controls, product code MOF).
Submitted by Scientia Vascular, LLC (West Valley City, US). The FDA issued a Cleared decision on August 7, 2018, 29 days after receiving the submission on July 9, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K181828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2018 |
| Decision Date | August 07, 2018 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |