21 CFR § 870.5175 Cardiovascular Devices

§ 870.5175 Septostomy catheter.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(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).

← § 870.5150 Embolectomy catheter.§ 870.5200 External cardiac compressor. →