510(k) K171954
K171954 is an FDA 510(k) premarket notification submitted by Clearline MD for the device "ClearLine IV". The FDA issued a decision of Substantially Equivalent on January 25, 2018. The device falls under product code OKL (Intravascular Administration Set, Automated Air Removal System), a Class II device regulated under 21 CFR 880.5445.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2018
- Date Received
- June 29, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intravascular Administration Set, Automated Air Removal System
- Device Class
- Class II
- Regulation Number
- 880.5445
- Review Panel
- HO
- Submission Type
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.