Cleared Traditional

BRACCO INJEENERING TRANSFER SET

K133147 · Bracco Injeneering S.A. · General Hospital
Jun 2014
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K133147 is an FDA 510(k) clearance for the BRACCO INJEENERING TRANSFER SET, a Iodinated Contrast Media Transfer Tubing Set (Class II — Special Controls, product code PQH), submitted by Bracco Injeneering S.A. (Nederland, US). The FDA issued a Cleared decision on June 20, 2014, 246 days after receiving the submission on October 17, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K133147 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2013
Decision Date June 20, 2014
Days to Decision 246 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code PQH — Iodinated Contrast Media Transfer Tubing Set
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440
Definition The Iodinated Contrast Media Transfer Set Is Intended To Transfer Iodinated Contrast Media From Imaging Bulk Package Contrast Media In A Controlled Ambient Environment. The Transfer Set Is Intended To Be Used To Directly Fill Multiple Sterile Single Use Syringes From An Imaging Bulk Package Contrast Media Bulk Package Under Controlled Ambient Filling Conditions Such As A Ct Suite.