Cleared Traditional

MEDRAD? Imaging Bulk Package Transfer Set

K173913 · Bayer U.S., LLC · General Hospital
May 2018
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K173913 is an FDA 510(k) clearance for the MEDRAD? Imaging Bulk Package Transfer Set, a Iodinated Contrast Media Transfer Tubing Set (Class II — Special Controls, product code PQH), submitted by Bayer U.S., LLC (Indianola, US). The FDA issued a Cleared decision on May 4, 2018, 133 days after receiving the submission on December 22, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K173913 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2017
Decision Date May 04, 2018
Days to Decision 133 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.