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FDA 510(k)

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System

K-Number: K173477 · 2018-08-31

ApplicantIcu Medical, Inc.
Decision Date2018-08-31
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is a medical device manufactured by Icu Medical, Inc.. It received FDA 510(k) clearance on 2018-08-31 under approval number K173477. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System?

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is a medical device that received FDA 510(k) clearance on 2018-08-31. It is manufactured by Icu Medical, Inc.. The 510(k) number is K173477.

When was ChemoCLAVE Cytotoxic Medication Preparation and Delivery System approved by the FDA?

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System received FDA 510(k) clearance on 2018-08-31, under approval number K173477.

What company makes ChemoCLAVE Cytotoxic Medication Preparation and Delivery System?

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is manufactured by Icu Medical, Inc..

What is the FDA product code for ChemoCLAVE Cytotoxic Medication Preparation and Delivery System?

The FDA product code for ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is ONB.

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Related PubMed Literature

PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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