21 CFR §870.1255

1. (a)Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)The device must be demonstrated to be biocompatible.
   2. (2)Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
   3. (3)Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
   4. (4)In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
   5. (5)Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.