K181353 is an FDA 510(k) clearance for the Lunderquist® Fixed Core Wire Guide. 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 February 15, 2019, 269 days after receiving the submission on May 22, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K181353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2018 |
| Decision Date | February 15, 2019 |
| Days to Decision | 269 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 |