K160643 is an FDA 510(k) clearance for the ENROUTE 0.014 Guidewire. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Lake Region Medical (Galway, IE). The FDA issued a Cleared decision on October 18, 2016, 225 days after receiving the submission on March 7, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K160643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2016 |
| Decision Date | October 18, 2016 |
| Days to Decision | 225 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 |