CytoSorbents Corporation (CTSO)

[BuyMyAsk]

Plowmaster I appreciate your input. Does the application and intended use of the device affect determination of 510(K)? IE: because CTSO is stating this will reduce Cytokines and other filters aren't on the market for that purpose, even though they are similiar to Cytosorb, does that mean we have to do PMA?

I am guessing Dr. Chan would have mentioned 510(K) a long time ago if he thought this was comparable to something else on the market. He is part of the medical community and knows the deal with these FDA type of things becuase he can seek advice from other medical and regulatory professionals. Also - they have stated they are trying to collect loads and loads of data. If that needed for 510(K)? Not really, right? They wouldn't need too much clinical data. Just enough to show safety.

Thoughts?