CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR

CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR is an FDA 510(k)-cleared medical device (K853425) manufactured by Cardio-Pace Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on August 18, 1985. Regulation: 8.