PXB · Percutaneous Introducer Kit
General Hospital · 21 CFR 880.5570 · Class 2
Overview
| Product Code | PXB |
|---|---|
| Device Name | Percutaneous Introducer Kit |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
