FAST-CATH (TM) INTRA-CARDIAC INTRODUCER

FAST-CATH (TM) INTRA-CARDIAC INTRODUCER is an FDA 510(k)-cleared medical device (K973840) manufactured by Daig 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 May 20, 1998. Regulation: 8.