
Alsius Corp.
Free shipping on orders over $99 · 30-day returns
COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D is an FDA 510(k)-cleared medical device (K014241) manufactured by Alsius Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 31, 2003. Regulation: 8.