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- 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.
 - K071778 FDA Clearance Letter
- K091491 FDA Clearance Letter
- K12006 FDA Clearance Letter
- K121532 FDA Clearance Letter
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INDICATIONS FOR USE: The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. Rx Only. See instructions for use for full indication, contraindication and caution statements. Terms and Conditions. Privacy Policy. HeRO is a Hemosphere, Inc. product distributed by CryoLife, Inc. HeRO, Hemosphere, CryoLife, ‘Life Restoring Technologies’, and the snowflake symbol are trademarks owned by CryoLife, Inc. or its subsidiaries. All other trademarks are owned by their respective companies. © 2012 CryoLife, Inc. All Rights Reserved.