
Guidant Cardiac and Vascular Surgery
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ANCURE LLIAC BALLOON CATHETER is an FDA 510(k)-cleared medical device (K003495) manufactured by Guidant Cardiac and Vascular Surgery. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 2001. Regulation: 8.