MitraClip G4 Steerable Guide Catheter

MitraClip G4 Steerable Guide Catheter is an FDA 510(k)-cleared medical device (K221397) manufactured by ABBOTT MEDICAL. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 27, 2022. Regulation: 8.