Cleared Traditional

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System

K173477 · Icu Medical, Inc. · General Hospital

Aug 2018

Decision

291d

Days

Class 2

Risk

About This 510(k) Submission

K173477 is an FDA 510(k) clearance for the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System, a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II — Special Controls, product code ONB), submitted by Icu Medical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on August 31, 2018, 291 days after receiving the submission on November 13, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K173477 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2017
Decision Date	August 31, 2018
Days to Decision	291 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5440
Definition	Reconstitute And Transfer Antineoplastic And Other Hazardous Drugs In Healthcare Setting Indicated To Reduce Exposure Of Healthcare Personnel To Chemotherapy Agents In Healthcare Setting.