510(k) K100739

VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 by Edwards Lifesciences, LLC — Product Code KRB

K100739 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5". The FDA issued a decision of Substantially Equivalent on December 7, 2010. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.