K021555 is an FDA 510(k) clearance for the STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM. This device is classified as a System, Catheter Control, Steerable (Class II - Special Controls, product code DXX).
Submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on January 15, 2003, 247 days after receiving the submission on May 13, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1290.
| 510(k) Number | K021555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2002 |
| Decision Date | January 15, 2003 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXX — System, Catheter Control, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1290 |