510(k) K150860
K150860 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Nitroglycerin Sets with DUO-VENT Spike". The FDA issued a decision of Substantially Equivalent on Apr 16, 2015. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corporation has 60 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 16, 2015
- Date Received
- Apr 1, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)