
Lumen Biomedical, Inc.
Free shipping on orders over $99 · 30-day returns
LBI CATHETER SYSTEM is an FDA 510(k)-cleared medical device (K053372) manufactured by Lumen Biomedical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 29, 2006. Regulation: 8.