CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS

CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS is an FDA 510(k)-cleared medical device (K120158) 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 August 13, 2012. Regulation: 8.