CytoSorbents Corporation (CTSO)

[Plowmaster]

Although it might take 9-12+ months for FDA clearance if they have to go through the CBER branch for 510(k) clearance and not the CDRH branch of the FDA (FDA has 3 branches for the drug/device process, CDER - Drugs, CBER - Biologics and Blood, CDRH - Device) because the input and output material is blood, CBER would probably review the 510(k) submitted. Unfortunately, CBER is notoriously difficult to deal with compared to CDRH.