Regulatory Information

  • 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. See Instructions for Use for full indication, contraindication and caution statements. Rx only.


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