510(k) K030456

VASC-ALERT by Vasc-Alert, LLC — Product Code KOC

K030456 is an FDA 510(k) premarket notification submitted by Vasc-Alert, LLC for the device "VASC-ALERT". The FDA issued a decision of Substantially Equivalent on July 11, 2003. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Vasc-Alert, LLC has at least 1 other 510(k) clearance on record.