FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER

FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER is an FDA 510(k)-cleared medical device (K061015) manufactured by St Jude Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 2006. Regulation: 8.