PERCUTANEOUS CATHETER INTRODUCER KIT

PERCUTANEOUS CATHETER INTRODUCER KIT is an FDA 510(k)-cleared medical device (K903906) manufactured by Intec Medical, 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 September 25, 1990. Regulation: 8.