• FDA Classification:
  

  The HeRO Vascular Access Device is classified by the FDA as a graft.

Intended Use:

The HeRO Vascular Access Device 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 Vascular Access Device is indicated for end-stage renal disease (ESRD) patients on long-term hemodialysis who have exhausted all other peripheral access options.

510K letter 2008

510K letter 2009