
Ep Dynamics, Inc.
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LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM is an FDA 510(k)-cleared medical device (K111603) manufactured by Ep Dynamics, 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 22, 2012. Regulation: 8.