OKL — Intravascular Administration Set, Automated Air Removal System Class II
FDA product code OKL covers "Intravascular Administration Set, Automated Air Removal System", a Class II medical device regulated under 21 CFR 880.5445. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OKL
- Device Class
- Class II
- Regulation Number
- 880.5445
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
An intravascular administration set, automated air removal system is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the IV fluid.