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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, 2012]
[CITE: 21CFR870.4360]
 See Related Information on 870.4360 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. 870.4360 Nonroller-type cardiopulmonary bypass blood pump.

(a)Identification. A nonroller-type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.

(b)Classification. Class III (premarket approval).

(c)Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See 870.3.

[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]

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