K090140 is an FDA 510(k) clearance for the GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER. This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by William Cook Europe Aps (Bloomington, US). The FDA issued a Cleared decision on April 3, 2009, 72 days after receiving the submission on January 21, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K090140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2009 |
| Decision Date | April 03, 2009 |
| Days to Decision | 72 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 |