UNIPOLAR UPSIZING ADAPTOR

UNIPOLAR UPSIZING ADAPTOR is an FDA 510(k)-cleared medical device (K912773) 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 October 22, 1991. Regulation: 8.