The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Vdrive With V-loop/ Vdrive Duo.
| Device ID | K140804 |
| 510k Number | K140804 |
| Device Name: | VDRIVE WITH V-LOOP/ VDRIVE DUO |
| Classification | System, Catheter Control, Steerable |
| Applicant | STEREOTAXIS, INC. 2995 STEVEN MARTIN DR, Fairfax, VA 22031 |
| Contact | Diane Horwitz, Ph.d., Rac |
| Correspondent | Diane 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 | 2014-03-31 |
| Decision Date | 2014-09-03 |
| Summary: | summary |