DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER

DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER is an FDA 510(k)-cleared medical device (K911883) manufactured by Diag Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 1991. Regulation: 8.