Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 mechanical thrombolysis catheter
Regulation Description Embolectomy catheter.
Definition To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
Physical State Peripheral catheter
Technical Method Fragments, macerates, or disrupts thrombus
Target Area Peripheral vasculature
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQEY
Premarket Review Office of Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.5150
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 Not Third Party Eligible
-
-