title: Medical Devices; Cardiovascular Devices; Classification of the   Steerable Cardiac Ablation Catheter Remote Control System. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the steerable cardiac ablation catheter remote control system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the steerable cardiac ablation catheter remote control system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D017115:Catheter Ablation / Q000145:classification* / Q000295:instrumentation*; D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D012371:Robotics / Q000145:classification / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration