Code of Federal Regulations · Section

§ 870.5175 — Septostomy Catheter

21 C.F.R. § 870.5175

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(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. § 870.5150 21 C.F.R. § 870.5200

Authorizing Statute