SOFIA EX Intracranial Support Catheter

SOFIA EX Intracranial Support Catheter is an FDA 510(k)-cleared medical device (K182602) manufactured by MicroVention, 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 May 14, 2019. Regulation: 8.