510(k) K960431

PRESSURE STOPCOCK/MANIFOLD by Scientific Device Manufacturer, LLC — Product Code FPA

K960431 is an FDA 510(k) premarket notification submitted by Scientific Device Manufacturer, LLC for the device "PRESSURE STOPCOCK/MANIFOLD". The FDA issued a decision of Substantially Equivalent on October 29, 1996. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Scientific Device Manufacturer, LLC has at least 5 other 510(k) clearances on record.