Clearance Summary
AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 received FDA 510(k) clearance under submission number K091007, sponsored by Sorin Group Deutschland GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-07-02.
- Submission: K091007
- Applicant / Sponsor: Sorin Group Deutschland GmbH
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4220
- Decision date: 2009-07-02
Classification & Regulation
This clearance is catalogued under FDA product code DTQ and 21 CFR 870.4220, within the Cardiovascular review panel as a Class II device.