SwiftNINJA Steerable Microcatheter

SwiftNINJA Steerable Microcatheter is an FDA 510(k)-cleared medical device (K211525) manufactured by Merit Medical Systems, 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 July 15, 2021. Regulation: 8.