K080637 is an FDA 510(k) clearance for the POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 12, 2008, 159 days after receiving the submission on March 6, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K080637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2008 |
| Decision Date | August 12, 2008 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| 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 |