§ 870.5175. Septostomy catheter.
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/us/cfr/t21/s§ 870.5175·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).