K121057 is an FDA 510(k) clearance for the COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS. This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by William Cook Europe Aps (West Lafayette, US). The FDA issued a Cleared decision on May 4, 2012, 28 days after receiving the submission on April 6, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K121057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2012 |
| Decision Date | May 04, 2012 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |