Surfacer Inside-Out Access Catheter System

DEN190038 is the FDA 510(k) clearance record for Surfacer Inside-Out Access Catheter System, a class II device, cleared for Bluegrass Vascular Technologies, Inc. on 2020-02-10 under FDA product code QJH (Reverse Central Venous Recanalization System). FDA's definition for product code QJH reads: "A reverse central venous recanalization system is a prescription device intended for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an...". FDA records list one 510(k) clearance for Bluegrass Vascular Technologies, Inc. As of 2026-09-10, FDA records show no recalls naming DEN190038.