21 CFR 882.5950 — Device, Neurovascular Embolization
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5950
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.
Classification Rationale
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HCG | Device, Neurovascular Embolization | 2 | 184 | Implant |
| MZQ | Balloon, Detachable, For Neurovascular Occlusion | 2 | 2 | Implant, Life-Sustaining |
Special Controls
HCG — Device, Neurovascular Embolization
*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).
eCFR
HCG — Device, Neurovascular Embolization
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).
Ecfr Llm
MZQ — Balloon, Detachable, For Neurovascular Occlusion
*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).
eCFR
