§ 876.5100. Suprapubic catheter accessories.
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/us/cfr/t21/s§ 876.5100·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.
(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]