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21 CFR 870.1240

§ 870.1240 Flow-directed catheter.

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

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21 CFR 870.1240, § 870.1240 Flow-directed catheter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89878
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Full text

(a) Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position. (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.