← Product Code [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF) · K905638 # SARNS INVENT CATHETERS (K905638) _3M Health Care, Sarns · DWF · Feb 1, 1991 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K905638 ## Device Facts - **Applicant:** 3M Health Care, Sarns - **Product Code:** [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF.md) - **Decision Date:** Feb 1, 1991 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4210 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Regulatory Identification A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K905638](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K905638) **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/DWF/K905638