K182985 is an FDA 510(k) clearance for the Roadrunner PC Wire Guide, Olcott Torque Device. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 22, 2019, 266 days after receiving the submission on October 29, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K182985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2018 |
| Decision Date | July 22, 2019 |
| Days to Decision | 266 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 |