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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter HPart 876Subpart F → §876.5100


Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart F—Therapeutic Devices


§876.5100   Suprapubic catheter accessories.

(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]

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