Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4410](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4410) → DTY — Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

# DTY · Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

_Cardiovascular · 21 CFR 870.4410 · Class 2_

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

## Overview

- **Product Code:** DTY
- **Device Name:** Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- **Regulation:** [21 CFR 870.4410](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4410)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K093650](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K093650.md) | BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM | Medtronic, Inc. | Feb 17, 2010 | SESE |
| [K963698](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K963698.md) | CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 | International Biophysics Corp. | Mar 20, 1997 | SESE |
| [K954501](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K954501.md) | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM | Medtronic Bio-Medicus, Inc. | Jan 16, 1996 | SESE |
| [K902654](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K902654.md) | CDI (TM) SYSTEM 100 MONITORING SYSTEM | 3M Health Care, Ltd. | Nov 5, 1990 | SESE |
| [K900860](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K900860.md) | PERFUSION MONITOR | Cardio Metrics, Inc. | Aug 14, 1990 | SESE |
| [K864703](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K864703.md) | MODIFIED GAS-STAT(TM) MONITORING SYSTEM | Cardiovascular Devices, Inc. | Feb 19, 1987 | SESE |
| [K840749](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K840749.md) | GAST STAT MONITORING SYSTEM | Cardiovascular Devices, Inc. | Apr 17, 1984 | SESE |
| [K822000](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K822000.md) | EXTRACORPOREAL BLOOD GAS SYSTEM | Cardiovascular Devices, Inc. | Dec 22, 1982 | SESE |

## Top Applicants

- Cardiovascular Devices, Inc. — 3 clearances
- Medtronic, Inc. — 1 clearance
- Medtronic Bio-Medicus, Inc. — 1 clearance
- International Biophysics Corp. — 1 clearance
- Cardio Metrics, Inc. — 1 clearance

---

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

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