510(k) K212588

Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter by C.R. Bard, Inc. — Product Code DQY

K212588 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter". The FDA issued a decision of Substantially Equivalent on May 4, 2022. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.