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LeMaitre Vascular, Inc.
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OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME is an FDA 510(k)-cleared medical device (K111884) 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 July 28, 2011. Regulation: 8.