Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set

Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set is an FDA 510(k)-cleared medical device (K233329) 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 22, 2024. Regulation: 8.