The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Vdrive With V-sono.
| Device ID | K133396 |
| 510k Number | K133396 |
| Device Name: | VDRIVE WITH V-SONO |
| Classification | Wire, Guide, Catheter |
| Applicant | STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 St. Louis, MO 63108 |
| Contact | Diane Horwitz, Ph.d. Rac |
| Correspondent | Diane Horwitz, Ph.d. Rac STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 St. Louis, MO 63108 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-06 |
| Decision Date | 2014-02-06 |
| Summary: | summary |