The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model is an FDA 510(k)-cleared medical device (K183066) 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 July 24, 2019. Regulation: 8.