Regulatory Text
21 C.F.R. § 876.5012 — Biliary stent, drain, and dilator accessories.
§ 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]
Source: ecfr.gov · govinfo.gov — public domain
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Root-LD v1.0 · boisestandard.org
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BS-CFR21-SEC-BD89C2
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REGULATION / FEDERAL-CFR-SECTION
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boisestandard.org
Citation
21 C.F.R. § 876.5012
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The regulatory text of 21 C.F.R. § 876.5012 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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21 C.F.R. — public domain
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