510(k) K161323
K161323 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Solution Set for Epidural Use". The FDA issued a decision of Substantially Equivalent on Nov 30, 2016. 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
- Nov 30, 2016
- Date Received
- May 11, 2016
- 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)