Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae

Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae is an FDA 510(k)-cleared medical device (K260195) manufactured by Medtronic, 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, 2026. Regulation: 8.