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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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[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR876.5012]
 See Related Information on Biliary stent, drain, and dilator accessories. 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 876 -- GASTROENTEROLOGY-UROLOGY DEVICES

Subpart F - Therapeutic Devices

Sec. 876.5012 Biliary stent, drain, and dilator accessories.

(a) Identification. Biliary stent, drain, and dilator accessories are manual devices that aid in the introduction and connection of biliary stents, drains, or dilators. This generic type of device includes the guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

[84 FR 14870, Apr. 12, 2019]

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