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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, 2013]
[CITE: 21CFR870.3375]
See Related Information on Cardiovascular intravascular filter. 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 D--Cardiovascular Prosthetic Devices

Sec. 870.3375 Cardiovascular intravascular filter.

(a)Identification. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.

(b)Classification. Class II. The special controls for this device are:

(1) "Use of International Standards Organization's ISO 10993 `Biological Evaluation of Medical Devices Part I: Evaluation and Testing,' " and

(2) FDA's:

(i) "510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)" and

(ii) "Guidance for Cardiovascular Intravascular Filter 510(k) Submissions."

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 65 FR 17144, Mar. 31, 2000]

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