Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5210](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5210) → PUK — Administration Set Securement Device

# PUK · Administration Set Securement Device

_General Hospital · 21 CFR 880.5210 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PUK

## Overview

- **Product Code:** PUK
- **Device Name:** Administration Set Securement Device
- **Regulation:** [21 CFR 880.5210](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5210)
- **Device Class:** 1
- **Review Panel:** [General Hospital](/submissions/HO)

## 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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PUK](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PUK)

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