Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is an FDA 510(k)-cleared medical device (K153226) manufactured by Zoll Circulation, 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 March 23, 2016. Regulation: 8.