Clearance Summary
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES received FDA 510(k) clearance under submission number K063114, sponsored by Coeur, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2007-02-09.
- Submission: K063114
- Applicant / Sponsor: Coeur, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2007-02-09
Classification & Regulation
This clearance is catalogued under FDA product code FPK and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.