ACS INDEFLATOR P/T 20

ACS INDEFLATOR P/T 20 is an FDA 510(k)-cleared medical device (K883452) manufactured by Advanced Cardiovascular Systems, 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 October 13, 1988. Regulation: 8.