LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM is an FDA 510(k)-cleared medical device (K152876) manufactured by Tni Manufacturing, 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 January 7, 2016. Regulation: 8.