TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform is an FDA 510(k)-cleared medical device (K212224) manufactured by Imperative Care, 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 September 19, 2021. Regulation: 8.