THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER is an FDA 510(k)-cleared medical device (K131300) 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 June 6, 2013. Regulation: 8.