The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Modification To Endovascular Guide Wire.
| Device ID | K043457 |
| 510k Number | K043457 |
| Device Name: | MODIFICATION TO ENDOVASCULAR GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis, MO 63108 |
| Contact | Gary Rauvola |
| Correspondent | Gary Rauvola STEREOTAXIS, INC. 4041 FOREST PARK AVE. 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 | 2004-12-15 |
| Decision Date | 2005-02-28 |
| Summary: | summary |