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U.S. Department of Health and Human Services

Product Classification
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Device catheter, thrombus retriever
Regulation Description Percutaneous catheter.
Definition The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke.The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature.It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
Regulation Medical Specialty Cardiovascular
Review Panel Neurology
Product CodeNRY
Submission Type 510(k)
Regulation Number 870.1250
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Pre-Clinical and Clinical Studies for Neurothrombectomy Devices
Third Party Review Not Third Party Eligible
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