Route 92 Medical 088 Access System, 110 cm

Route 92 Medical 088 Access System, 110 cm is an FDA 510(k)-cleared medical device (K200121) manufactured by Route 92 Medical, 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 April 17, 2020. Regulation: 8.