MICRO-TRACHEOSTOMY CARE KIT

MICRO-TRACHEOSTOMY CARE KIT is an FDA 510(k)-cleared medical device (K861645) manufactured by Aci Medical, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 8, 1986. Regulation: 8.