← Product Code [DWD](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD) · K895427 # MEDISEAL SUCTION CANISTER (K895427) _Deroyal Industries, Inc. · DWD · Jan 19, 1990 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K895427 ## Device Facts - **Applicant:** Deroyal Industries, Inc. - **Product Code:** [DWD](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD.md) - **Decision Date:** Jan 19, 1990 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4430 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Regulatory Identification A cardiopulmonary bypass intracardiac suction control is a device which provides the vacuum and control for a cardiotomy return sucker. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K895427](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K895427) **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/DWD/K895427