Route 92 Medical Full Length 088 Access System

Route 92 Medical Full Length 088 Access System is an FDA 510(k)-cleared medical device (K210635) 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 July 26, 2021. Regulation: 8.