510(k) K982203

CAAS II LVA BIPLANE OPTION by Pie Medical Equipment B.V. — Product Code IZI

K982203 is an FDA 510(k) premarket notification submitted by Pie Medical Equipment B.V. for the device "CAAS II LVA BIPLANE OPTION". The FDA issued a decision of Substantially Equivalent on July 14, 1998. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Pie Medical Equipment B.V. has at least 7 other 510(k) clearances on record.