APRO 55 Intermediate Catheter

APRO 55 Intermediate Catheter is an FDA 510(k)-cleared medical device (K250962) manufactured by Alembic, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 28, 2025. Regulation: 8.