SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER

SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER is an FDA 510(k)-cleared medical device (K052644) 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 December 4, 2005. Regulation: 8.