Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4400](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4400) → MNJ — Valve, Pressure Relief, Cardiopulmonary Bypass

# MNJ · Valve, Pressure Relief, Cardiopulmonary Bypass

_Cardiovascular · 21 CFR 870.4400 · Class 2_

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

## Overview

- **Product Code:** MNJ
- **Device Name:** Valve, Pressure Relief, Cardiopulmonary Bypass
- **Regulation:** [21 CFR 870.4400](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4400)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

## Classification Rationale

Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Special Controls

*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K992964](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MNJ/K992964.md) | IBC VENT VALVE, MODEL 1400 | International Biophysics Corp. | Nov 19, 1999 | SESE |
| [K941492](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MNJ/K941492.md) | PRESSURE RELIEF VALVE | Circulatory Technology, Inc. | Oct 26, 1994 | SESE |

## Top Applicants

- International Biophysics Corp. — 1 clearance
- Circulatory Technology, Inc. — 1 clearance

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

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