510(k) K061115
K061115 is an FDA 510(k) premarket notification submitted by Gvs Spa for the device "SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216". The FDA issued a decision of Substantially Equivalent on Jun 30, 2006. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 30, 2006
- Date Received
- Apr 21, 2006
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)