MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE

MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE is an FDA 510(k)-cleared medical device (K863418) manufactured by Intermedics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on September 23, 1986. Regulation: 8.