Next Generation Aspiration Catheter; Balt Aspiration Tubing Set

Next Generation Aspiration Catheter; Balt Aspiration Tubing Set is an FDA 510(k)-cleared medical device (K234083) manufactured by Balt USA, 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 July 1, 2024. Regulation: 8.