510(k) K152633

Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe by Edwards Lifesciences, LLC — Product Code LDF

K152633 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe". The FDA issued a decision of Substantially Equivalent on October 15, 2015. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.