§ 882.5950. Neurovascular embolization device.
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/us/cfr/t21/s§ 882.5950·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
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§ 882.5950
Neurovascular embolization device.
Fed. Reg.×4
C.F.R.×1
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