QOI · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5220
Classification
FDA Product Code
QOI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.5220
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.