DQG · Microsphere, Trace
Cardiovascular · 21 CFR 870.1360 · Class 3
Overview
| Product Code | DQG |
|---|---|
| Device Name | Microsphere, Trace |
| Regulation | 21 CFR 870.1360 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A trace microsphere is a radioactively tagged nonbiodegradable particle that is intended to be injected into an artery or vein and trapped in the capillary bed for the purpose of studying blood flow within or to an organ.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
