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Kerberos Proximal Solutions, Inc.
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RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 is an FDA 510(k)-cleared medical device (K062275) manufactured by Kerberos Proximal Solutions, 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 September 19, 2006. Regulation: 8.