The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Vdrive System/ Vdrive Duo/ Vdrive With V-cas.
| Device ID | K141530 |
| 510k Number | K141530 |
| Device Name: | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS |
| Classification | System, Catheter Control, Steerable |
| Applicant | STEREOTAXIS, INC. 2995 STEVEN MARTIN DR, Fairfax, VA 22031 |
| Contact | Diana Horwitz, Ph.d., Rac |
| Correspondent | Diana Horwitz, Ph.d., Rac STEREOTAXIS, INC. 2995 STEVEN MARTIN DR, 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 | 2014-06-09 |
| Decision Date | 2014-12-18 |
| Summary: | summary |