MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7

MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 is an FDA 510(k)-cleared medical device (K080500) 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 March 12, 2008. Regulation: 8.