Clearance Summary
Cathivex ¿GV filter units received FDA 510(k) clearance under submission number K143583, sponsored by Merck Millipore , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2015-08-11.
- Submission: K143583
- Applicant / Sponsor: Merck Millipore , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2015-08-11
Classification & Regulation
This clearance is catalogued under FDA product code FPB and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.