MAMBA and MAMBA Flex Microcatheters

MAMBA and MAMBA Flex Microcatheters is an FDA 510(k)-cleared medical device (K190401) 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 March 14, 2019. Regulation: 8.