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FDA 510(k), K173477, ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
FDA 510(k), K173477, ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
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510(K) Number: K173477
Device Name: ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
Manufacturer: ICU Medical, Inc.
Device Classification Name: closed antineoplastic and hazardous drug reconstitution and transfer system
Regulation Number: 880.5440
Classification Product Code: ONB
Date Received: 11/13/2017
Decision Date: 08/31/2018
Regulation Medical Specialty: General Hospital
Device Name: ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
Manufacturer: ICU Medical, Inc.
Device Classification Name: closed antineoplastic and hazardous drug reconstitution and transfer system
Regulation Number: 880.5440
Classification Product Code: ONB
Date Received: 11/13/2017
Decision Date: 08/31/2018
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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