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Lepu Medical Technology (Beijing) Co., Ltd.
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HOPER PTCA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K123473) manufactured by Lepu Medical Technology (Beijing) Co., Ltd.. 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 12, 2013. Regulation: 8.