510(k) DEN080009
DEN080009 is an FDA 510(k) premarket notification submitted by Anesthesia Safety Products, LLC for the device "AIRPURGE". The FDA issued a decision of De Novo Granted on March 4, 2014. 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
- DENG (De Novo Granted)
- Decision Date
- March 4, 2014
- Date Received
- October 29, 2008
- Clearance Type
- Post-NSE
- 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.