510(k) K000820

AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 by Endosonics Corp. — Product Code DQO

K000820 is an FDA 510(k) premarket notification submitted by Endosonics Corp. for the device "AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700". The FDA issued a decision of Substantially Equivalent on June 5, 2000. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Endosonics Corp. has at least 10 other 510(k) clearances on record.