The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Vdrive W/v-sono.
| Device ID | K122659 |
| 510k Number | K122659 |
| Device Name: | VDRIVE W/V-SONO |
| Classification | Wire, Guide, Catheter |
| Applicant | STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 St. Louis, MO 63108 |
| Contact | Horwitz |
| Correspondent | Horwitz 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-31 |
| Decision Date | 2013-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M58800100246910 | K122659 | 000 |