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21 CFR 870.5175

§ 870.5175 Septostomy catheter.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 870.5175, § 870.5175 Septostomy catheter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90023
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Full text

(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).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.