• 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 sensor, pressure, aneurysm, implantable
Regulation Description Implantable Intra-aneurysm Pressure Measurement System.
Definition This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNQH
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.2855
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible