← Product Code [DTQ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ) · K870976

# ONGUARD 1000, CATALOG #043611-000 & 043611-001 (K870976)

_Cobe Laboratories, Inc. · DTQ · May 6, 1987 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K870976

## Device Facts

- **Applicant:** Cobe Laboratories, Inc.
- **Product Code:** [DTQ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ.md)
- **Decision Date:** May 6, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4220
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K870976](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K870976)

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