
Cardiomems, Inc.
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CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 is an FDA 510(k)-cleared medical device (K070448) manufactured by Cardiomems, 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 March 14, 2007. Regulation: 8.