Clearance Summary
OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER received FDA 510(k) clearance under submission number K140286, sponsored by Cordis, A Johnson & Johnson Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-03-07.
- Submission: K140286
- Applicant / Sponsor: Cordis, A Johnson & Johnson Co.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3375
- Decision date: 2014-03-07
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.