← Product Code [DTR](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR) · K883331 # BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10 (K883331) _Shiley, Inc. · DTR · Sep 26, 1988 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K883331 ## Device Facts - **Applicant:** Shiley, Inc. - **Product Code:** [DTR](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR.md) - **Decision Date:** Sep 26, 1988 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4240 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Regulatory Identification A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K883331](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K883331) **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/DTR/K883331