← Product Code [DTZ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ) · K802328 # DISP. TOUGY-BORST TYPE ADAPTOR W/PORT (K802328) _Stanco Medical, Inc. · DTZ · Oct 10, 1980 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K802328 ## Device Facts - **Applicant:** Stanco Medical, Inc. - **Product Code:** [DTZ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ.md) - **Decision Date:** Oct 10, 1980 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4350 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Regulatory Identification A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery. ## Special Controls *Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.” --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K802328](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K802328) **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/DTZ/K802328