K140608 is an FDA 510(k) clearance for the MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Merit Medical Systems, Inc. (Galway, IE). The FDA issued a Cleared decision on September 12, 2014, 186 days after receiving the submission on March 10, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K140608 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2014 |
| Decision Date | September 12, 2014 |
| Days to Decision | 186 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 |