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U.S. Department of Health and Human Services

Product Classification

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Device neurovascular mechanical thrombectomy device for acute ischemic stroke treatment
Definition A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes.The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.
Physical State The device is delivered into the neurovasculature with an endovascular approach and mechanically removes thrombus from the body and restores blood flow.
Technical Method The device is delivered into the neurovasculature with an endovascular approach and mechanically removes thrombus from the body and restores blood flow.
Target Area Neurovasculature
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePOL
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurointerventional Devices Branch (NIDB)
Submission Type 510(k)
Regulation Number 882.5600
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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