PWH

Administrations Sets With Neuraxial Connectors

Product code

PWH

Device name

Administrations Sets With Neuraxial Connectors

Device class

Class 2

21 CFR

21 CFR 880.5440

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification definition

The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.

Definition text from the FDA device classification database (U.S. federal government work, public domain).