K051373 is an FDA 510(k) clearance for the CRONUS GUIDEWIRE, MODEL 001-001470-1. This device is classified as a System, Catheter Or Guidewire, Steerable (magnetic) (Class II - Special Controls, product code NDQ).
Submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on December 9, 2005, 197 days after receiving the submission on May 26, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1290.
| 510(k) Number | K051373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2005 |
| Decision Date | December 09, 2005 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NDQ — System, Catheter Or Guidewire, Steerable (magnetic) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1290 |