510(k) K990514

MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR by C.R. Bard, Inc. — Product Code DTP

K990514 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR". The FDA issued a decision of Substantially Equivalent on March 9, 1999. The device falls under product code DTP (Defoamer, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4230. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.