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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 870 - Cardiovascular Devices |
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Subpart B - Cardiovascular Diagnostic Devices |
§ 870.1250 - Percutaneous catheter.
Latest version.
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§ 870.1250 Percutaneous catheter.
(a) Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
(b) Classification. Class II (performance standards).