Capture Vascular | Regulatory Strategy
page,page-id-16607,page-template,page-template-full_width,page-template-full_width-php,ajax_fade,page_not_loaded,,qode-child-theme-ver-1.0.0,qode-theme-ver-10.1,wpb-js-composer js-comp-ver-5.0.1,vc_responsive

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