21 CFR 882.5950

§ 882.5950 Neurovascular embolization device.

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

Cite this

Citation: 21 CFR 882.5950, § 882.5950 Neurovascular embolization device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90767
Permanent ID: ys:prov:90767@1
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Full text

(a) Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300. (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 § 882.1(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.