(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]