MZQ · Balloon, Detachable, For Neurovascular Occlusion
Neurology · 21 CFR 882.5950 · Class 2
Overview
| Product Code | MZQ |
|---|---|
| Device Name | Balloon, Detachable, For Neurovascular Occlusion |
| Regulation | 21 CFR 882.5950 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
| Life-Sustaining | Yes |
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).
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).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K965071 | DETACHABLE SLICONE BALLOON (DSB) | Target Therapeutics | Apr 21, 1998 | SESE |
| K964488 | DETACHABLE SILICONE BALLOON (DSB) | Target Therapeutics | Apr 21, 1998 | SESE |
Top Applicants
- Target Therapeutics — 2 clearances
