• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device hemodialysis system for home use
Definition To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Physical State Complex machine consisting of pumps, monitors, and tubing.
Technical Method A machine that dialyzes the patient's blood.
Target Area Connects to the patient's blood stream
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeONW
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.5860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-