MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130

MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 is an FDA 510(k)-cleared medical device (K040552) manufactured by Cryocor, 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 May 27, 2004. Regulation: 8.