IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)

IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION) is an FDA 510(k)-cleared medical device (K960466) manufactured by Abbott Laboratories. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 1996. Regulation: 8.