510(k) K111016

SAFEPORT MANIFOLD (TM) (OR STOPCOCK) by Elcam Medical Acal — Product Code FPA

K111016 is an FDA 510(k) premarket notification submitted by Elcam Medical Acal for the device "SAFEPORT MANIFOLD (TM) (OR STOPCOCK)". The FDA issued a decision of Substantially Equivalent on June 9, 2011. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Elcam Medical Acal has at least 10 other 510(k) clearances on record.