← Product Code [DTM](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM) · K813131 # INTERFACE ARTERIAL BLOOD FILTER (K813131) _Medical, Inc. · DTM · Nov 27, 1981 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K813131 ## Device Facts - **Applicant:** Medical, Inc. - **Product Code:** [DTM](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM.md) - **Decision Date:** Nov 27, 1981 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4260 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Regulatory Identification A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line. ## Special Controls *Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.” --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K813131](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K813131) **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/DTM/K813131