K120834 is an FDA 510(k) clearance for the CORPATH 200 SYSTEM. This device is classified as a System, Catheter Control, Steerable (Class II - Special Controls, product code DXX).
Submitted by Corindus, Inc. (Baltimore, US). The FDA issued a Cleared decision on July 19, 2012, 122 days after receiving the submission on March 19, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1290.
| 510(k) Number | K120834 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2012 |
| Decision Date | July 19, 2012 |
| Days to Decision | 122 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 |