StacksVerified U.S. regulatory reference

21 CFR §870.1240

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.
  2. (b)Classification. Class II (performance standards).