PUK · Administration Set Securement Device
General Hospital · 21 CFR 880.5210 · Class 1
Overview
| Product Code | PUK |
|---|---|
| Device Name | Administration Set Securement Device |
| Regulation | 21 CFR 880.5210 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
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.
