21 C.F.R. § 870.5175

Septostomy catheter.

Last amended: 2016Year: 2026Length: 34 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 870.5175 (2026)

(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. (b) Classification. Class II (performance standards).
21 C.F.R. § 870.5175: Septostomy catheter. | Justis AI