Clearance Summary
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM received FDA 510(k) clearance under submission number K101046, sponsored by Sorin Group Deutschland GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-12-09.
- Submission: K101046
- Applicant / Sponsor: Sorin Group Deutschland GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4300
- Decision date: 2010-12-09
Classification & Regulation
This clearance is catalogued under FDA product code DTX and 21 CFR 870.4300, within the Cardiovascular review panel as a Class II device.