StacksVerified U.S. regulatory reference

21 CFR §870.5175

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.
  2. (b)Classification. Class II (performance standards).