這套設備可能（注意是可能）還沒有最後通過FDA批準？
Both the MegaVac and ThromboWire devices have received FDA clearance for thrombectomy and temporary occlusion of blood flow. Much of the regulatory risk has already been mitigated and this clearance will be used to commercialize the device quickly. Capture will obtain an additional 510(k) to build on the initial clearance. The technology features a strong patent portfolio, with 10 existing patents (freedom to operate) and 3 patent applications.
來源：
http://www.capturevascular.com/wp-content/uploads/2014/04/Capture-2-Pg-Executive-Summary-v2.pdf
