MAXIMA FORTE HARDSHELL VENOUS RESERVOIR

MAXIMA FORTE HARDSHELL VENOUS RESERVOIR is an FDA 510(k)-cleared medical device (K961836) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 31, 1996. Regulation: 8.