21 C.F.R. § 870.1240Download PDFCurrent through September 30, 2024Section 870.1240 - Flow-directed catheter(a)Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)Classification. Class II (performance standards). 21 C.F.R. § 870.1240