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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR870.4075]
See Related Information on Endomyocardial biopsy device. 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. 870.4075 Endomyocardial biopsy device.

(a) Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.

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

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