LifeSPARC Pump, LifeSPARC Controller

LifeSPARC Pump, LifeSPARC Controller is an FDA 510(k)-cleared medical device (K183623) manufactured by Cardiacassist, 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 July 8, 2019. Regulation: 8.