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LeMaitre Vascular, Inc.
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UNBALLOON NON-OCCLUSIVE MODELING CATHETER is an FDA 510(k)-cleared medical device (K121839) manufactured by LeMaitre Vascular, 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 7, 2012. Regulation: 8.