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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
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
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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