CytoSorbents Corporation (CTSO)

[Plowmaster]

Ideally this won't matter. They should be able to go through the 510(k) process as a class II and avoid a PMA. Yes the could very well end up PMA if the FDA decides it's a Class III, but seems they should be able to find a 'substantially equivalent' (in terms of safety and filtration as a primary mode of action) cleared medical device in the 510(k) database.

It would generally decrease time and costs, though they would need to complete a registered clinical trial.

Once submitted it should take 6-9 months to clear. Though as stated before CBER would probably handle this 510(k) and not CDRH so that could make things more difficult as they are notoriously more difficult to work with