Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4340](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4340) → DTW — Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

# DTW · Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

_Cardiovascular · 21 CFR 870.4340 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/DTW

## Overview

- **Product Code:** DTW
- **Device Name:** Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- **Regulation:** [21 CFR 870.4340](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4340)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.

## Classification Rationale

Class II (special controls). The device 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). The device 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 (17 of 17)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K150530](/device/K150530.md) | Level Sensor, Level Sensor Tape | Medtronic, Inc. | May 8, 2015 | SESE |
| [K041558](/device/K041558.md) | STOCKERTIR PURGE CONTROL (APC) SYSTEM | Stockert Instrumente GmbH | Jul 2, 2004 | SESE |
| [K992857](/device/K992857.md) | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 | Rocky Mountain Research, Inc. | Nov 10, 1999 | SESE |
| [K955152](/device/K955152.md) | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER | Stoeckert Instrumente | Feb 22, 1996 | SESE |
| [K910599](/device/K910599.md) | CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR | Jtl Medical Corp. | May 20, 1993 | SESE |
| [K924354](/device/K924354.md) | STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR | Sorin Biomedica, Fiat, USA, Inc. | Feb 18, 1993 | SESE |
| [K915337](/device/K915337.md) | CAPIOX LEVEL ALARM | Terumo Medical Corp. | Feb 21, 1992 | SESE |
| [K900910](/device/K900910.md) | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) | Cobe Laboratories, Inc. | May 22, 1990 | SESE |
| [K900815](/device/K900815.md) | SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL | 3M Company | May 9, 1990 | SESE |
| [K873206](/device/K873206.md) | MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE | Respiratory Support Products, Inc. | Sep 30, 1987 | SESE |
| [K860076](/device/K860076.md) | GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 | Gambro, Inc. | May 30, 1986 | SESE |
| [K852407](/device/K852407.md) | SENSOR TAPE CAT. NO. ST-45 | American Omni Medical, Inc. | Oct 21, 1985 | SESE |
| [K843802](/device/K843802.md) | STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR | Shiley, Inc. | Dec 27, 1984 | SESE |
| [K831879](/device/K831879.md) | UNIVERSAL LEVEL SENSOR | 3M Health Care, Sarns | Jul 26, 1983 | SESE |
| [K823712](/device/K823712.md) | BEL BLOOD LEVEL DETECTOR | R. Scott Bell | Feb 7, 1983 | SESE |
| [K822821](/device/K822821.md) | GAMBRO BLOOD LEVEL DETECTOR LCS 10 | Gambro, Inc. | Oct 18, 1982 | SESE |
| [K781145](/device/K781145.md) | MONITOR KITS, BLOOD LEVEL | 3M Health Care, Sarns | Jul 27, 1978 | SESE |

## Top Applicants

- 3M Health Care, Sarns — 2 clearances
- Gambro, Inc. — 2 clearances
- 3M Company — 1 clearance
- American Omni Medical, Inc. — 1 clearance
- Cobe Laboratories, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/DTW](https://fda.innolitics.com/productcode/DTW)

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