510(k) K080679

MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 by Viasys Medsystems — Product Code KNT

K080679 is an FDA 510(k) premarket notification submitted by Viasys Medsystems for the device "MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900". The FDA issued a decision of Substantially Equivalent on June 27, 2008. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Viasys Medsystems has at least 6 other 510(k) clearances on record.