• 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 catheter, flow directed
Regulation Description Flow-directed catheter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDYG
Premarket Review Cardiovascular Devices (OHT2)
Coronary and Peripheral Intervention Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.1240
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
-
-