the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model is an FDA 510(k)-cleared medical device (K162322) manufactured by Access Scientific, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 16, 2016. Regulation: 8.