Cleared Traditional

BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE

K123213 · Becton, Dickinson & CO · General Hospital

Jan 2013

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K123213 is an FDA 510(k) clearance for the BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE, 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 January 9, 2013, 86 days after receiving the submission on October 15, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K123213 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 2012
Decision Date	January 09, 2013
Days to Decision	86 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.