LARGE BORE SPLITTABLE INTRODUCER KIT

LARGE BORE SPLITTABLE INTRODUCER KIT is an FDA 510(k)-cleared medical device (K043438) manufactured by Thomas Medical Products, 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 February 14, 2005. Regulation: 8.