21 CFR 870.5150

§ 870.5150 Embolectomy catheter.

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

Cite this

Citation: 21 CFR 870.5150, § 870.5150 Embolectomy catheter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90022
Permanent ID: ys:prov:90022@1
SHA-256: c59f15548b3af6cec5f0d58a79dd7ce7e9bcd877739e53b98b2d28d0632be600

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Full text

(a) Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another. (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.