 |
Code of Federal Regulations (Last Updated: November 8, 2024) |
 |
Title 21 - Food and Drugs |
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
SubChapter H - Medical Devices |
|
Part 882 - Neurological Devices |
|
Subpart F - Neurological Therapeutic Devices |
§ 882.5950 - Neurovascular embolization device.
Latest version.
-
§ 882.5950 Neurovascular embolization device.
(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).
[69 FR 77900, Dec. 29, 2004]