SORIN MONOLYTH VENOUS RESERVOIR

SORIN MONOLYTH VENOUS RESERVOIR is an FDA 510(k)-cleared medical device (K933481) manufactured by Sorin Biomedical, 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 November 1, 1993. Regulation: 8.