ChemoCLAVE Cytotoxic Medication Preparation And Delivery System

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

ICU Medical, Inc.

The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Chemoclave Cytotoxic Medication Preparation And Delivery System.

Pre-market Notification Details

Device IDK173477
510k NumberK173477
Device Name:ChemoCLAVE Cytotoxic Medication Preparation And Delivery System
ClassificationClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant ICU Medical, Inc. 600 N. Field Drive Lake Forest,  IL  60045
ContactCatherine E. Kang
CorrespondentCatherine E. Kang
ICU Medical, Inc. 600 N. Field Drive Lake Forest,  IL  60045
Product CodeONB  
Subsequent Product CodeFPA
Subsequent Product CodeLHI
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-13
Decision Date2018-08-31
Summary:summary

NIH GUDID Devices

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