DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000

DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000 is an FDA 510(k)-cleared medical device (K894131) manufactured by Thermedics, 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, 1989. Regulation: 8.