DTY · Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4410 · Class 2
Overview
| Product Code | DTY |
|---|---|
| Device Name | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4410 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM | Medtronic, Inc. | Feb 17, 2010 | SESE |
| K963698 | CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 | International Biophysics Corp. | Mar 20, 1997 | SESE |
| K954501 | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM | Medtronic Bio-Medicus, Inc. | Jan 16, 1996 | SESE |
| K902654 | CDI (TM) SYSTEM 100 MONITORING SYSTEM | 3M Health Care, Ltd. | Nov 5, 1990 | SESE |
| K900860 | PERFUSION MONITOR | Cardio Metrics, Inc. | Aug 14, 1990 | SESE |
| K864703 | MODIFIED GAS-STAT(TM) MONITORING SYSTEM | Cardiovascular Devices, Inc. | Feb 19, 1987 | SESE |
| K840749 | GAST STAT MONITORING SYSTEM | Cardiovascular Devices, Inc. | Apr 17, 1984 | SESE |
| K822000 | 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
