Agilis HisPro Steerable Catheter With Electrodes

Agilis HisPro Steerable Catheter With Electrodes is an FDA 510(k)-cleared medical device (K200721) manufactured by Abbott (St. Jude Medical). This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 2020. Regulation: 8.