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Vesalio Announces FDA 510(k) Clearance of pVasc NET, a Next-Generation Peripheral ...
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Fusion42 · 13 August 2026 · Fusion42 review
Vesalio has received FDA 510(k) clearance for its pVasc NET, a next-generation peripheral mechanical thrombectomy device featuring an integrated distal filter.
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You can now compete in the US market with a cleared peripheral thrombectomy device that reduces embolic risks. This opens immediate US commercial opportunities but also demands rapid compliance with FDA post-clearance standards.
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