BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)

BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) is an FDA 510(k)-cleared medical device (K972017) manufactured by Minntech 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 September 9, 1997. Regulation: 8.