ACUMEN SINGLE-LUMEN DELIVERY SHEATH

ACUMEN SINGLE-LUMEN DELIVERY SHEATH is an FDA 510(k)-cleared medical device (K053400) manufactured by Acumen Medical, 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 18, 2006. Regulation: 8.