Clearance Summary
COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D received FDA 510(k) clearance under submission number K014241, sponsored by Alsius Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-08-01.
- Submission: K014241
- Applicant / Sponsor: Alsius Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 2003-08-01
Classification & Regulation
This clearance is catalogued under FDA product code NCX and 21 CFR 870.5900, within the Cardiovascular review panel as a Class II device.