Surfacer Inside-Out Access Catheter System

Surfacer Inside-Out Access Catheter System is an FDA 510(k)-cleared medical device (DEN190038) manufactured by Bluegrass Vascular Technologies, 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 February 9, 2020. Regulation: 8.