EMBOGOLD MICROSPHERE
Device Facts
| Record ID | K010026 |
|---|---|
| Device Name | EMBOGOLD MICROSPHERE |
| Applicant | Biosphere Medical, Inc. |
| Product Code | HCG · Neurology |
| Decision Date | Jun 21, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.5950 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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).
