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GUIDANCE DOCUMENT

Pre-Clinical and Clinical Studies for Neurothrombectomy Devices Guidance for Industry and FDA Staff June 2007

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document describes FDA’s recommendations for pre-clinical and clinical studies that involve neurothrombectomy devices conducted to support premarket submissions for neurothrombectomy devices indicated for ischemic stroke. A neurothrombectomy device is intended to retrieve or destroy blood clots in the cerebral neurovasculature by mechanical (i.e., snare or suction), laser, ultrasound technologies, or combination of technologies.

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All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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