NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter is an FDA 510(k)-cleared medical device (K220171) manufactured by Northeast Scientific, 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 June 30, 2022. Regulation: 8.