PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS

PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS is an FDA 510(k)-cleared medical device (K954431) manufactured by Boston Scientific Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 1996. Regulation: 8.