K142598 is an FDA 510(k) clearance for the Opto Wire and OptoMonitor System. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Opsens, Inc. (Quebec, CA). The FDA issued a Cleared decision on June 12, 2015, 270 days after receiving the submission on September 15, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K142598 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2014 |
| Decision Date | June 12, 2015 |
| Days to Decision | 270 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 |