FDA Product Code PWH: Administrations Sets With Neuraxial Connectors
The Connector For Neuraxial Applications Is Intended To Facilitate Ansi/aami/iso 80369-6:2016 Compliant Neuraxial Specific Connections.
Leading manufacturers include Baxter Healthcare Corporation and Care Fusion.
4
Total
4
Cleared
307d
Avg days
2017
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Administrations Sets With Neuraxial Connectors Devices (Product Code PWH)
4 devices
Cleared
Jul 21, 2023
BD Alaris™ Pump Epidural Infusion Set
Care Fusion
General Hospital
441d
Cleared
Nov 23, 2021
PCEA Syringe Set
Baxter Healthcare Corporation
General Hospital
179d
About Product Code PWH - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PWH since 2017, with 4 receiving FDA clearance (average review time: 307 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
PWH devices are reviewed by the General Hospital panel. Browse all General Hospital devices →