510(k) K030141

MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 by Cardiovention, Inc. — Product Code DTQ

K030141 is an FDA 510(k) premarket notification submitted by Cardiovention, Inc. for the device "MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100". The FDA issued a decision of Substantially Equivalent on February 26, 2003. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Cardiovention, Inc. has at least 3 other 510(k) clearances on record.