Clearance Summary
COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS received FDA 510(k) clearance under submission number K121057, sponsored by William Cook Europe Aps. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-05-04.
- Submission: K121057
- Applicant / Sponsor: William Cook Europe Aps
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3375
- Decision date: 2012-05-04
Classification & Regulation
This clearance is catalogued under FDA product code DTK and 21 CFR 870.3375, within the Cardiovascular review panel as a Class II device.