NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON

NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON is an FDA 510(k)-cleared medical device (K860638) manufactured by Kontron Instruments, 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 September 30, 1986. Regulation: 8.