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LeMaitre Vascular, Inc.
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DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) is an FDA 510(k)-cleared medical device (K032041) 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 26, 2003. Regulation: 8.