The following data is part of a premarket notification filed by William Cook Europe Aps with the FDA for Cook Celect And Gunther Tulip Vena Cava Filter Sets.
| Device ID | K121057 |
| 510k Number | K121057 |
| Device Name: | COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | WILLIAM COOK EUROPE APS ONE GEDDES WAY West Lafayette, IN 47906 |
| Contact | Jennifer Brown |
| Correspondent | Jennifer Brown WILLIAM COOK EUROPE APS ONE GEDDES WAY West Lafayette, IN 47906 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-06 |
| Decision Date | 2012-05-04 |
| Summary: | summary |