APRO 70 Swift Catheter and Alembic Aspiration Tubing

APRO 70 Swift Catheter and Alembic Aspiration Tubing is an FDA 510(k)-cleared medical device (K243287) 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 February 23, 2025. Regulation: 8.