The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Vdrive System, Vdrive Duo, Vdrive With V-sono.
| Device ID | K150312 |
| 510k Number | K150312 |
| Device Name: | Vdrive System, Vdrive Duo, Vdrive With V-Sono |
| Classification | System, Catheter Control, Steerable |
| Applicant | STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 St. Louis, MO 63108 |
| Contact | John Nadelin |
| Correspondent | Diane Horwitz SAFIS SOLUTIONS LLC 2995 STEVEN MARTIN DRIVE Fairfax, VA 22031 |
| Product Code | DXX |
| CFR Regulation Number | 870.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-09 |
| Decision Date | 2015-06-17 |
| Summary: | summary |