MAMBA and MAMBA FLEX Microcatheters

MAMBA and MAMBA FLEX Microcatheters is an FDA 510(k)-cleared medical device (K171452) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 2017. Regulation: 8.