
Cardioquip Llp
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CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 is an FDA 510(k)-cleared medical device (K102147) manufactured by Cardioquip Llp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 2010. Regulation: 8.