Medical Devices; Cardiovascular Devices; Classification of the Intravascular Bleed Monitor

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The Food and Drug Administration (FDA or we) is classifying the intravascular bleed monitor into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intravascular bleed monitor's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.