510(k) K012143

24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 by Medtronic Cardiac Surgical Products — Product Code DRA

K012143 is an FDA 510(k) premarket notification submitted by Medtronic Cardiac Surgical Products for the device "24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524". The FDA issued a decision of Substantially Equivalent on October 24, 2001. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Medtronic Cardiac Surgical Products has at least 6 other 510(k) clearances on record.