The following data is part of a premarket notification filed by William Cook Europe Aps with the FDA for Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set.
| Device ID | K073374 |
| 510k Number | K073374 |
| Device Name: | COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-03 |
| Decision Date | 2008-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002483781 | K073374 | 000 |
| 00827002483736 | K073374 | 000 |
| 00827002483729 | K073374 | 000 |