K043457 is an FDA 510(k) clearance for the MODIFICATION TO ENDOVASCULAR GUIDE WIRE. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on February 28, 2005, 75 days after receiving the submission on December 15, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K043457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2004 |
| Decision Date | February 28, 2005 |
| Days to Decision | 75 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |