K150312 is an FDA 510(k) clearance for the Vdrive system, Vdrive Duo, Vdrive with V-Sono. This device is classified as a System, Catheter Control, Steerable (Class II - Special Controls, product code DXX).
Submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 17, 2015, 128 days after receiving the submission on February 9, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1290.
| 510(k) Number | K150312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2015 |
| Decision Date | June 17, 2015 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXX — System, Catheter Control, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1290 |