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Biotronik, Inc.
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SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H is an FDA 510(k)-cleared medical device (K060655) manufactured by Biotronik, 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 April 3, 2006. Regulation: 8.