The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Cronus Guidewire, Model 001-001470-1.
| Device ID | K051373 |
| 510k Number | K051373 |
| Device Name: | CRONUS GUIDEWIRE, MODEL 001-001470-1 |
| Classification | System, Catheter Or Guidewire, Steerable (magnetic) |
| Applicant | STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis, MO 63108 |
| Contact | Kelly Rowland |
| Correspondent | Kelly Rowland STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis, MO 63108 |
| Product Code | NDQ |
| CFR Regulation Number | 870.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-26 |
| Decision Date | 2005-12-09 |
| Summary: | summary |