Reprocessed Agilis NxT Steerable Introducer

Reprocessed Agilis NxT Steerable Introducer is an FDA 510(k)-cleared medical device (K250305) manufactured by Innovative Health. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 2026. Regulation: 8.