§870.3300. Vascular embolization device. — Inbound Citations
21 C.F.R. § 870.3300
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 870.3300 as a whole
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(a) 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.