Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
The In-Line Blood-Gas Sensor for Cardiopulmonary Bypass is a cardiovascular device placed directly within the extracorporeal circuit to provide continuous real-time measurement of blood oxygen, carbon dioxide, and pH levels during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTY and it is regulated under 21 CFR 870.4410 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DTY
- Device Class
- FDA class 2
- Regulation Number
- 870.4410
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093650 | BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM | Feb 17, 2010 | Substantially Equivalent | Medtronic, Inc. |
| K963698 | CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 | Mar 20, 1997 | Substantially Equivalent | International Biophysics Corp. |
| K954501 | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM | Jan 16, 1996 | Substantially Equivalent | Medtronic Bio-Medicus, Inc. |
| K902654 | CDI (TM) SYSTEM 100 MONITORING SYSTEM | Nov 05, 1990 | Substantially Equivalent | 3M Health Care, Ltd. |
| K900860 | PERFUSION MONITOR | Aug 14, 1990 | Substantially Equivalent | Cardio Metrics, Inc. |
| K864703 | MODIFIED GAS-STAT(TM) MONITORING SYSTEM | Feb 19, 1987 | Substantially Equivalent | Cardiovascular Devices, Inc. |
| K840749 | GAST STAT MONITORING SYSTEM | Apr 17, 1984 | Substantially Equivalent | Cardiovascular Devices, Inc. |
| K822000 | EXTRACORPOREAL BLOOD GAS SYSTEM | Dec 22, 1982 | Substantially Equivalent | Cardiovascular Devices, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.