The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Powerasset Radiofrequency Guidwire, Model Various.
| Device ID | K080637 |
| 510k Number | K080637 |
| Device Name: | POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS |
| Classification | Wire, Guide, Catheter |
| Applicant | STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 St. Louis, MO 63108 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo 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 | 2008-03-06 |
| Decision Date | 2008-08-12 |
| Summary: | summary |