Cleared Traditional

CHEMOLOCK, CHEMOLOCK PORT

K131549 · Icu Medical, Inc. · General Hospital

Jul 2013

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K131549 is an FDA 510(k) clearance for the CHEMOLOCK, CHEMOLOCK PORT, a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II — Special Controls, product code ONB), submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 26, 2013, 58 days after receiving the submission on May 29, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K131549 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 2013
Decision Date	July 26, 2013
Days to Decision	58 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.