• 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 extracorporeal system for long-term respiratory / cardiopulmonary failure
Regulation Description Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Definition Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Physical State May include an oxygenator, pump, and other components needed for perfusion.
Technical Method Device removes blood from blood vessels and pumps blood through an oxygenator for gas exchange and returns the blood to the blood vessels.
Target Area Blood vessels, heart, lungs.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQJZ
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4100
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? Yes
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
-
-