EsoCool Thermal Regulation Catheter

EsoCool Thermal Regulation Catheter is an FDA 510(k)-cleared medical device (K233357) manufactured by Nuvaira, 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 June 26, 2024. Regulation: 8.