FDA.reportPublic FDA data

Central venous catheter inside-out introduction set

Definition
A collection of sterile, invasive devices intended to enable introduction of a central venous catheter (CVC) into an occluded vein (e.g., subclavian) by creating a puncture site from the inside of the vein under fluoroscopic guidance. It typically includes: an introducer sheath, for initial vascular access via a secondary vein (e.g., femoral); a semi-rigid, noncoring, endovascular guide sheath assembly with a distal side-hole, intended to navigate into, and be stabilized by, the vascular occlusion; a percutaneous needle-wire, intended to puncture the vein/tissue to exit at the skin surface; and a sheath for introduction of a CVC; the catheter is not included. This is a single-use device.
GUDID devices
47
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840155409811Sonostik Single Port ClearSafe CatheterMEDSOURCE INTERNATIONAL LLCMS-871162021-09-17
00840155409866Sonostik Single Port ClearSafe CatheterMEDSOURCE INTERNATIONAL LLCMS-871182021-09-17
00840155409897Sonostik Single Port ClearSafe CatheterMEDSOURCE INTERNATIONAL LLCMS-871202021-09-17
00840155409927Sonostik Single Port ClearSafe CatheterMEDSOURCE INTERNATIONAL LLCMS-871222021-09-17
00840155409958Sonostik Single Port ClearSafe CatheterMEDSOURCE INTERNATIONAL LLCMS-871242021-09-17
00840155409989Sonostik Single Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-872162021-09-17
00840155410015Sonostik Single Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-872182021-09-17
00840155410046Sonostik Single Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-872202021-09-17
00840155410077Sonostik Single Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-872222021-09-17
00840155410107Sonostik Single Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-872242021-09-17
00840155410138Sonostik Dual Port ClearSafe CatheterMEDSOURCE INTERNATIONAL LLCMS-873162021-09-17
00840155410169Sonostik Dual Port ClearSafe CatheterMEDSOURCE INTERNATIONAL LLCMS-873182021-09-17
00840155410206Sonostik Dual Port ClearSafe CatheterMEDSOURCE INTERNATIONAL LLCMS-873202021-09-17
00840155410220Sonostik Dual Port ClearSafe CatheterMEDSOURCE INTERNATIONAL LLCMS-873222021-09-17
00840155410251Sonostik Dual Port ClearSafe CatheterMEDSOURCE INTERNATIONAL LLCMS-873242021-09-17
00840155410282Sonostik Dual Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-874162021-09-17
00840155410312Sonostik Dual Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-874182021-09-17
00840155410343Sonostik Dual Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-874202021-09-17
00840155410374Sonostik Dual Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-874222021-09-17
00840155410404Sonostik Dual Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-874242021-09-17
00840155413634Sonostik Single Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-872142022-09-26
00840155413665Sonostik Single Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-8722022022-09-26
00884450419809Surfacer®Merit Medical Systems, Inc.F2026-02-18
00884450762158Surfacer®Merit Medical Systems, Inc.C2024-03-02
00840155413641Sonostik Single Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-872142022-09-26
00840155413672Sonostik Single Port ClearSafe Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-8722022022-09-26
00840155409835Sonsotik Single Port CatheterMEDSOURCE INTERNATIONAL LLCMS-871162021-09-17
00840155409873Sonsotik Single Port CatheterMEDSOURCE INTERNATIONAL LLCMS-871182021-09-17
00840155409903Sonsotik Single Port CatheterMEDSOURCE INTERNATIONAL LLCMS-871202021-09-17
00840155409934Sonsotik Single Port CatheterMEDSOURCE INTERNATIONAL LLCMS-871222021-09-17
00840155409965Sonsotik Single Port CatheterMEDSOURCE INTERNATIONAL LLCMS-871242021-09-17
00840155409996Sonsotik Single Port Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-872162021-09-17
00840155410022Sonsotik Single Port Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-872182021-09-17
00840155410053Sonsotik Single Port Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-872202021-09-17
00840155410084Sonsotik Single Port Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-872222021-09-17
00840155410114Sonsotik Single Port Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-872242021-09-17
00840155410145Sonsotik Dual Port CatheterMEDSOURCE INTERNATIONAL LLCMS-873162021-09-17
00840155410176Sonsotik Dual Port CatheterMEDSOURCE INTERNATIONAL LLCMS-873182021-09-17
00840155410190Sonsotik Dual Port CatheterMEDSOURCE INTERNATIONAL LLCMS-873202021-09-17
00840155410237Sonsotik Dual Port CatheterMEDSOURCE INTERNATIONAL LLCMS-873222021-09-17
00840155410268Sonsotik Dual Port CatheterMEDSOURCE INTERNATIONAL LLCMS-873242021-09-17
00840155410299Sonsotik Dual Port Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-874162021-09-17
00840155410329Sonsotik Dual Port Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-874182021-09-17
00840155410350Sonsotik Dual Port Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-874202021-09-17
00840155410381Sonsotik Dual Port Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-874222021-09-17
00840155410411Sonsotik Dual Port Comfort CatheterMEDSOURCE INTERNATIONAL LLCMS-874242021-09-17
00860003451601Surfacer Inside-Out Access Catheter SystemBLUEGRASS VASCULAR TECHNOLOGIES, INC.600200/A2020-02-27