CytoSorbents Corporation (CTSO)

[orangecat]

If the medical device is classified as a certain class, I think class 2, and there is a substantially equivalent medical device already approved for marketing the 510K regulatory route can be taken. This route should require a relatively smaller and shorter trial. Alternatively, the PMA route can be taken which will require a larger and longer study to prove clinical efficacy. I believe Cytosorb is "Class 2 with special controls".