Cleared Special

BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR

K140591 · Becton, Dickinson & CO · General Hospital

May 2014

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K140591 is an FDA 510(k) clearance for the BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR, a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II — Special Controls, product code ONB), submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on May 14, 2014, 68 days after receiving the submission on March 7, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K140591 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 2014
Decision Date	May 14, 2014
Days to Decision	68 days
Submission Type	Special
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.