MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),

MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), is an FDA 510(k)-cleared medical device (K000105) manufactured by Medtronic Vascular. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 11, 2000. Regulation: 8.