K034050 is an FDA 510(k) clearance for the CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B. This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by Cordis Corporation (Warren, US). The FDA issued a Cleared decision on March 22, 2004, 83 days after receiving the submission on December 30, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K034050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2003 |
| Decision Date | March 22, 2004 |
| Days to Decision | 83 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 |