QOI

Intravenous Catheter Force-Activated Separation Device.

Product code

QOI

Device name

Intravenous Catheter Force-Activated Separation Device.

Device class

Class 2

21 CFR

21 CFR 880.5220

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

8 (all years; only the last 3 years are listed here)

FDA classification definition

An intravenous (IV) catheter force-activated separation device. An intravenous catheter force-activated separation device is placed inline with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2024-09-06.

3 summaries are archived here for direct download.