510(k) K911384

CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 by Endosonics Corp. — Product Code DXK

K911384 is an FDA 510(k) premarket notification submitted by Endosonics Corp. for the device "CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600". The FDA issued a decision of Substantially Equivalent on June 25, 1991. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Endosonics Corp. has at least 10 other 510(k) clearances on record.