← Product Code [JOD](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD) · K780653

# EXTRACORPEAL CARDIOTOMY BLOOD FILTER (K780653)

_Cobe Laboratories, Inc. · JOD · Jun 14, 1978 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K780653

## Device Facts

- **Applicant:** Cobe Laboratories, Inc.
- **Product Code:** [JOD](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD.md)
- **Decision Date:** Jun 14, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4270
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K780653](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K780653)

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