← Product Code [DTQ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ) · K002118 # STOCKERT COMPACT SYSTEM VERSION 2.0 (K002118) _Stoeckert Instrumente · DTQ · Aug 9, 2000 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K002118 ## Device Facts - **Applicant:** Stoeckert Instrumente - **Product Code:** [DTQ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ.md) - **Decision Date:** Aug 9, 2000 - **Decision:** SESE - **Submission Type:** Special - **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. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K002118](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K002118) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K002118