COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331

COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 is an FDA 510(k)-cleared medical device (K991102) manufactured by Guidant Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 1999. Regulation: 8.