21 CFR 870.3300

§ 870.3300 Vascular embolization device.

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

Cite this

Citation: 21 CFR 870.3300, § 870.3300 Vascular embolization device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89957
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Full text

(a) Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter. (b) Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Legislative history

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