ee2bede7-e034-4cde-b7ce-6eff5eaf63cdUpdatePublished42023-02-212014-09-29In Commercial Distribution05414734300193PrimaryGS1Safireā¢ TX402843402843926346966IRVINE BIOMEDICAL, INC.1Ablation CatheterfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseMR Unsafetruefalse+1(855)478-5833customerservice@sjm.comP040042009P04004205261785Cardiac radio-frequency ablation system catheterA sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.falseActiveOADcatheter, percutaneous, cardiac ablation, for treatment of atrial flutterCatheter GaugeSpecial Storage Condition, SpecifyStore in a cool, dry place.truefalse