Route 92 Medical Full Length 070 Access System

Route 92 Medical Full Length 070 Access System is an FDA 510(k)-cleared medical device (K222743) 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 October 3, 2022. Regulation: 8.