SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515

SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 is an FDA 510(k)-cleared medical device (K013029) 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 October 8, 2001. Regulation: 8.