The following data is part of a premarket notification filed by William Cook Europe Aps with the FDA for Cunther Tulip(r) Vena Cava Filter Set For Femoral Approach, Cook Celect(r) Vena Cava Filter For Femoral Approach.
| Device ID | K112119 |
| 510k Number | K112119 |
| Device Name: | CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-25 |
| Decision Date | 2012-03-30 |