K140804 is an FDA 510(k) clearance for the VDRIVE WITH V-LOOP/ VDRIVE DUO. This device is classified as a System, Catheter Control, Steerable (Class II - Special Controls, product code DXX).
Submitted by Stereotaxis, Inc. (Fairfax, US). The FDA issued a Cleared decision on September 3, 2014, 156 days after receiving the submission on March 31, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1290.
| 510(k) Number | K140804 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2014 |
| Decision Date | September 03, 2014 |
| Days to Decision | 156 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 |