510(k) K031903

RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 by Guidant Corporation — Product Code DTZ

K031903 is an FDA 510(k) premarket notification submitted by Guidant Corporation for the device "RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568". The FDA issued a decision of Substantially Equivalent on March 3, 2004. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Guidant Corporation has at least 10 other 510(k) clearances on record.