Clearance Summary
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR received FDA 510(k) clearance under submission number K073339, sponsored by Fenwal, Inc.. 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 2008-03-03.
- Submission: K073339
- Applicant / Sponsor: Fenwal, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2008-03-03
Classification & Regulation
This clearance is catalogued under FDA product code BRZ and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.