Apical closure device.Medical equipment (ICS: 11.040)

Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device (2 pages, in English)

The Food and Drug Administration (FDA) is classifying the apicalclosure device into class II (special controls). The special controls that will apply to thedevice are identified in this order and will be part of the codified language for the apicalclosure device's classification. The Agency is classifying the device into class II (specialcontrols) in order to provide a reasonable assurance of safety and effectiveness of thedevice.