21 CFR 880.5210 — Device, Intravascular Catheter Securement

General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5210

Identification

An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.

Classification Rationale

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 § 880.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KMKDevice, Intravascular Catheter Securement164
PUKAdministration Set Securement Device10
Innolitics

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