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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.