HBZ · Catheter, Intravascular Occluding
Neurology · 21 CFR 882.5150 · Class 3
Overview
| Product Code | HBZ |
|---|---|
| Device Name | Catheter, Intravascular Occluding |
| Regulation | 21 CFR 882.5150 |
| Device Class | Class 3 |
| Review Panel | Neurology |
Identification
An intravascular occluding catheter is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms (balloonlike sacs formed on blood vessels) of intracranial blood vessels.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
