21 CFR § 876.5100
Suprapubic catheter accessories
June 25, 2020
(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.CITA>[84 FR 14870, Apr. 12, 2019]
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