POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107

POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107 is an FDA 510(k)-cleared medical device (K853446) manufactured by Cardiac Control Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on January 12, 1986. Regulation: 8.