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 Smiths Medical Asd, Inc., 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
Cleared
May 17, 2018
CADD Yellow High Volume Administration Set with NRFit connector
Smiths Medical Asd, Inc.
General Hospital
261d
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.