
Cardio Systems, Inc.
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MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM is an FDA 510(k)-cleared medical device (K081944) manufactured by Cardio 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 August 13, 2008. Regulation: 8.