Where in the US does Mykovia's intra-aortic balloon counterpulsation pump belong?

DatascopeCorp, USA. The CARDIOSAVEHybrid intra-aortic balloon counterpulsation pump is a Class III medical device for use as an endoscopic surgical aid and medical optics This product is clinically indicated for use in adult patients to inflate and deflate the aortic balloon, providing temporary support to the left ventricle through the counterpulsation principle.