NEW LEAD INTRODUCER KITS, VARIOUS MODELS

NEW LEAD INTRODUCER KITS, VARIOUS MODELS is an FDA 510(k)-cleared medical device (K926340) manufactured by Telectronics Pacing Systems, 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 26, 1993. Regulation: 8.