Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1660](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1660) → DXL — Injector, Indicator

# DXL · Injector, Indicator

_Cardiovascular · 21 CFR 870.1660 · Class 2_

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

## Overview

- **Product Code:** DXL
- **Device Name:** Injector, Indicator
- **Regulation:** [21 CFR 870.1660](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1660)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

An indicator injector is an electrically or gas-powered device designed to inject accurately an indicator solution into the blood stream. This device may be used in conjuction with a densitometer or thermodilution device to determine cardiac output.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K760500](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXL/K760500.md) | TUBE, HEAVY GLASS WALL INJECTION | Unimetrics Corp. | Sep 3, 1976 | SESE |
| [K760448](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXL/K760448.md) | SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT | Instrumentation Laboratory CO | Aug 27, 1976 | SESE |
| [K760066](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXL/K760066.md) | TRAY, ICED INJECTABLE (26420) | Instrumentation Laboratory CO | Jul 21, 1976 | SESE |

## Top Applicants

- Instrumentation Laboratory CO — 2 clearances
- Unimetrics Corp. — 1 clearance

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

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