CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS

CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS is an FDA 510(k)-cleared medical device (K902475) manufactured by Cardio-Pak. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 2, 1990. Regulation: 8.