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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR870.4310]
 See Related Information on Cardiopulmonary bypass coronary pressure gauge. in CDRH databases



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 E - Cardiovascular Surgical Devices

Sec. 870.4310 Cardiopulmonary bypass coronary pressure gauge.

(a) Identification. A cardiopulmonary bypass coronary pressure gauge is a device used in cardiopulmonary bypass surgery to measure the pressure of the blood perfusing the coronary arteries.

(b) Classification. Class II (performance standards).

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