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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: 21CFR870.3800]
 See Related Information on Annuloplasty ring. 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. 870.3800 Annuloplasty ring.

(a) Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.

(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled "Guidance for Annuloplasty Rings 510(k) Submissions."

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 FR 18542, Apr. 10, 2001]

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