The following data is part of a premarket notification filed by William Cook Europe Aps with the FDA for Cook Celect Platinum Vena Cava Filter Set For Femoral Approach Cook Celect Platium Vena Cava Filter Set For Jugular Appr.
| Device ID | K121629 |
| 510k Number | K121629 |
| Device Name: | COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | WILLIAM COOK EUROPE APS 1 Geddes Way West Lafayette, IN 47906 |
| Contact | Jennifer Brown |
| Correspondent | Jennifer Brown WILLIAM COOK EUROPE APS 1 Geddes Way West Lafayette, IN 47906 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-04 |
| Decision Date | 2012-07-03 |
| Summary: | summary |