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) → MJJ — Cpb Check Valve, Retrograde Flow, In-Line

# MJJ · Cpb Check Valve, Retrograde Flow, In-Line

_Cardiovascular · 21 CFR 870.4400 · Class 2_

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

## Overview

- **Product Code:** MJJ
- **Device Name:** Cpb Check Valve, Retrograde Flow, In-Line
- **Regulation:** [21 CFR 870.4400](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4400)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## 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 (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K182442](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ/K182442.md) | MiniGuard Arterial Safety Valve | Quest Medical, Inc. | Nov 6, 2018 | SESE |
| [K142500](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ/K142500.md) | One Way Soft Valve | Terumo Cardiovascular Systems Corporation | Jan 29, 2015 | SESE |
| [K001245](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ/K001245.md) | 3T L. V. CONTROL VALVE | 3t Medical Systems, LLC | Aug 15, 2001 | SESE |
| [K992785](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ/K992785.md) | IBC FLOGUARD, MODEL 6050 | International Biophysics Corp. | Jan 14, 2000 | SESE |
| [K982406](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ/K982406.md) | COBE VACUUM RELIEF CHECK VALVE | Cobe Cardiovascular, Inc. | Oct 7, 1998 | SESE |
| [K960937](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ/K960937.md) | SUCTION SAFETY DEVICE | R D Intl. | Jun 5, 1996 | SESE |
| [K922781](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ/K922781.md) | FLOW CONROL VALVE | American Omni Medical, Inc. | Mar 8, 1993 | SESE |
| [K922356](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ/K922356.md) | FLOW CONTROL VALVE, CAT. NO. ACV-38 | American Omni Medical, Inc. | Feb 12, 1993 | SESE |
| [K921500](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ/K921500.md) | CENTRI-SAFE(TM) VALVE | Cardio Systems, Inc. | Sep 15, 1992 | SESE |

## Top Applicants

- American Omni Medical, Inc. — 2 clearances
- 3t Medical Systems, LLC — 1 clearance
- Cardio Systems, Inc. — 1 clearance
- Cobe Cardiovascular, Inc. — 1 clearance
- International Biophysics Corp. — 1 clearance

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

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