• 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 actuator, syringe, for injector, reprocessed
Regulation Description Syringe actuator for an injector.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNKW
Premarket Review Coronary and Peripheral Interventional Devices (DHT2C)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.1670
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
-
-