Cleared Traditional

CADD? Infusion Disposables Portfolio with NRFit? connectors

K162219 · Smiths Medical Asd, Inc. · General Hospital

Jul 2017

Decision

346d

Days

Class 2

Risk

About This 510(k) Submission

K162219 is an FDA 510(k) clearance for the CADD? Infusion Disposables Portfolio with NRFit? connectors, a Administrations Sets With Neuraxial Connectors (Class II — Special Controls, product code PWH), submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 20, 2017, 346 days after receiving the submission on August 8, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K162219 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2016
Decision Date	July 20, 2017
Days to Decision	346 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PWH — Administrations Sets With Neuraxial Connectors
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5440
Definition	The Connector For Neuraxial Applications Is Intended To Facilitate Ansi/aami/iso 80369-6:2016 Compliant Neuraxial Specific Connections.