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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.