510(k) K172584
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach by
William Cook Europe Aps
— Product Code DTK
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2017
- Date Received
- August 28, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Intravascular, Cardiovascular
- Device Class
- Class II
- Regulation Number
- 870.3375
- Review Panel
- CV
- Submission Type