Cleared Traditional

Diana ChemoClave Transfer Set

K190157 · Icu Medical · General Hospital

Oct 2019

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K190157 is an FDA 510(k) clearance for the Diana ChemoClave Transfer Set, a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II — Special Controls, product code ONB), submitted by Icu Medical (Lake Forest, US). The FDA issued a Cleared decision on October 23, 2019, 266 days after receiving the submission on January 30, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K190157 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2019
Decision Date	October 23, 2019
Days to Decision	266 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.