CCC · Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Anesthesiology · 21 CFR 868.1150 · Class 2
Overview
| Product Code | CCC |
|---|---|
| Device Name | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling |
| Regulation | 21 CFR 868.1150 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K071165 | ISCALERT SENSOR SYSTEM | Alertis Medical AS | Nov 7, 2007 | SESE |
| K983198 | TRENDCARE CALIBRATOR MODEL SCU 7007 | Diametrics Medical, Ltd. | Nov 23, 1999 | SESE |
| K972314 | PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM | Diametrics Medical, Ltd. | Dec 19, 1997 | SESE |
| K953893 | PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM | Biomedical Sensors, Inc. | Nov 4, 1997 | SESE |
| K961790 | POINT-OF-CARE BLOOD GAS MONITOR SYSTEM | Optical Sensors, Inc. | Apr 9, 1997 | SESE |
| K963935 | OLYMPUS CRITICAL CARE MONITORING SYSTEM | Optical Sensors, Inc. | Jan 23, 1997 | SESE |
| K951094 | POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM | Optical Sensors, Inc. | Jan 16, 1996 | SESE |
| K940188 | PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM | Biomedical Sensors, Ltd. | Nov 13, 1995 | SESE |
| K931185 | SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE | Optical Sensors, Inc. | Oct 21, 1993 | SESE |
| K901548 | BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS | Shiley, Inc. | Jan 14, 1991 | SESE |
| K891013 | MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING | Medtronic Vascular | Aug 2, 1989 | SESE |
| K870911 | INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY | American Bentley | May 29, 1987 | SESE |
| K780185 | OXYGEN ANALYZER 110 | Siemens Corp. | Mar 17, 1978 | SESE |
| K771722 | SENSOMAT | Biochem International, Inc. | Sep 26, 1977 | SESE |
| K760088 | ANALYZER, SENTORR BLOOD GAS | Ohio Medical Products | Aug 6, 1976 | SESE |
Top Applicants
- Optical Sensors, Inc. — 4 clearances
- Diametrics Medical, Ltd. — 2 clearances
- Siemens Corp. — 1 clearance
- Shiley, Inc. — 1 clearance
- Ohio Medical Products — 1 clearance
