Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1360](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1360) → DQG — Microsphere, Trace

# DQG · Microsphere, Trace

_Cardiovascular · 21 CFR 870.1360 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQG

## Overview

- **Product Code:** DQG
- **Device Name:** Microsphere, Trace
- **Regulation:** [21 CFR 870.1360](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1360)
- **Device Class:** 3
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **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._

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQG](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQG)

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