510(k) K982329

VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) by Endosonics Corp. — Product Code ITX

K982329 is an FDA 510(k) premarket notification submitted by Endosonics Corp. for the device "VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)". The FDA issued a decision of Substantially Equivalent on January 14, 1999. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Endosonics Corp. has at least 10 other 510(k) clearances on record.