SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES

SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES is an FDA 510(k)-cleared medical device (K930218) manufactured by Concord/Portex. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 1993. Regulation: 8.