Clearance Summary
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 received FDA 510(k) clearance under submission number K013523, sponsored by Shire Biologics, 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 2002-01-07.
- Submission: K013523
- Applicant / Sponsor: Shire Biologics, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2002-01-07
Classification & Regulation
This clearance is catalogued under FDA product code LHI and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.