Capture Vascular | Regulatory Strategy
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Regulatory Strategy

MegaVac and ThromboWire have already achieved FDA 510(k)-clearance,
both as a system (K040010) and as individual stand-alone devices (K092623).
Capture Vascular has obtained a worldwide exclusive license for the technology
in the fields of thrombectomy and embolic protection.
Both 510(k) clearances have the following indications:


The non-surgical removal of emboli and thrombi from blood vessels



The non-surgical removal of thrombi from synthetic grafts



Use in temporary blood vessel/graft occlusion



Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft



Catheter placement over a guidewire