Reprocessed Agilis NxT Steerable Introducer

Reprocessed Agilis NxT Steerable Introducer is an FDA 510(k)-cleared medical device (K230376) manufactured by Innovative Health, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 6, 2023. Regulation: 8.