The following data is part of a premarket notification filed by William Cook Europe Aps with the FDA for Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter.
| Device ID | K090140 |
| 510k Number | K090140 |
| Device Name: | GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | WILLIAM COOK EUROPE APS 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 -0489 |
| Contact | Molly Busenbark |
| Correspondent | Molly Busenbark WILLIAM COOK EUROPE APS 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 -0489 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-04-03 |
| Summary: | summary |