• FDA Classification:

  The HeRO Graft is classified by the FDA as a vascular graft prosthesis.

Intended Use:

The HeRO Graft is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts.

Indications For Use:

The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options.

510K letter 2008

510K letter 2009