Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4270](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4270) → JOD — Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass

# JOD · Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass

_Cardiovascular · 21 CFR 870.4270 · Class 2_

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

## Overview

- **Product Code:** JOD
- **Device Name:** Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- **Regulation:** [21 CFR 870.4270](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4270)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K993060](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K993060.md) | GAS FILTER | Olson Medical Sales, Inc. | Mar 28, 2000 | SESE |
| [K890504](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K890504.md) | CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS | Gish Biomedical, Inc. | Mar 10, 1989 | SESE |
| [K875095](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K875095.md) | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | Feb 29, 1988 | SESE |
| [K874405](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K874405.md) | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | Pall Biomedical Products Co. | Dec 30, 1987 | SESE |
| [K855067](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K855067.md) | SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 | Cobe Laboratories, Inc. | Feb 26, 1986 | SESE |
| [K841958](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K841958.md) | CARDIO METRICS CARDIOTOMY RESERVOIR | Sterile Design, Inc. | Oct 15, 1984 | SESE |
| [K830634](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K830634.md) | CARDIOTOMY FILTER | Texas Medical Products, Inc. | Jun 30, 1983 | SESE |
| [K823260](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K823260.md) | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Medical, Inc. | Nov 24, 1982 | SESE |
| [K823259](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K823259.md) | INTERFACE CARDIOTOMY BLOOD FILTER #50 | Medical, Inc. | Nov 24, 1982 | SESE |
| [K812243](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K812243.md) | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Medical, Inc. | Aug 25, 1981 | SESE |
| [K781383](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K781383.md) | INTERFACE CARDIOTOMY BLOOD FILTER | Medical, Inc. | Sep 27, 1978 | SESE |
| [K780653](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/JOD/K780653.md) | EXTRACORPEAL CARDIOTOMY BLOOD FILTER | Cobe Laboratories, Inc. | Jun 14, 1978 | SESE |

## Top Applicants

- Medical, Inc. — 4 clearances
- Pall Biomedical Products Co. — 2 clearances
- Cobe Laboratories, Inc. — 2 clearances
- Texas Medical Products, Inc. — 1 clearance
- Sterile Design, Inc. — 1 clearance

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

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