510(k) K211649
K211649 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "PCEA Syringe Set". The FDA issued a decision of Substantially Equivalent on November 23, 2021. The device falls under product code PWH (Administrations Sets With Neuraxial Connectors), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2021
- Date Received
- May 28, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Administrations Sets With Neuraxial Connectors
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.