VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02

VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 is an FDA 510(k)-cleared medical device (K081258) manufactured by Biosense Webster, 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 January 5, 2009. Regulation: 8.