Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Alsius Corp.
Free shipping on orders over $99 · 30-day returns
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B is an FDA 510(k)-cleared medical device (K051912) 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 October 10, 2005. Regulation: 8.