Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 870 - Cardiovascular Devices |
Subpart C - Cardiovascular Monitoring Devices |
§ 870.2870 - Catheter tip pressure transducer.
Latest version.
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§ 870.2870 Catheter tip pressure transducer.
(a) Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.
(b) Classification. Class II (performance standards).