K161218 is an FDA 510(k) clearance for the Gianturco-Roehm Bird’s Nest Vena Cava Filter. This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 22, 2016, 84 days after receiving the submission on April 29, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K161218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2016 |
| Decision Date | July 22, 2016 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTK — Filter, Intravascular, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3375 |