INFUSASLEEVE IIA (IS-2A)

INFUSASLEEVE IIA (IS-2A) is an FDA 510(k)-cleared medical device (K972175) manufactured by Localmed, 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 August 27, 1997. Regulation: 8.