• 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 occluder, catheter tip
Regulation Description Catheter tip occluder.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDQT
Premarket Review Cardiovascular Devices (OHT2)
Coronary and Peripheral Intervention Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.1370
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
-
-