Clearance Summary
SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET received FDA 510(k) clearance under submission number K022477, sponsored by Summit Medical , 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 2002-10-25.
- Submission: K022477
- Applicant / Sponsor: Summit Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2002-10-25
Classification & Regulation
This clearance is catalogued under FDA product code CAK and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.