Requests that the FDA require the manufacturer and any sponsors studying the Vena MicroAngioscope System (K251767 and K253842) (Vena MicroAngioscope) for neurovascular use, particularly in neurointerventional procedures including acute ischemic stroke thrombectomy, to apply for an Investigational Device Exemption (IDE)
🏛 Food and Drug Administration (FDA)FDA-2026-P-6948
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