MEDRAD® Imaging Bulk Package Transfer Set

FDA 510(k) K173913 · Bayer U.S., LLC

Substantially Equivalent

510(k) numberK173913

Submission

Device name
MEDRAD® Imaging Bulk Package Transfer Set
Applicant
Bayer U.S., LLC
Indianaola, PA, US
Received
December 22, 2017
Decision date
May 4, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PQH – Iodinated Contrast Media Transfer Tubing Set
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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.

Other 510(k)s with product code PQH

510(k)DeviceApplicantDecision
K253688MEDRAD® Imaging Bulk Package Transfer SpikePQH · Traditional Bayer Medical Care, Inc.06/12/2026SE
K193010Liebel-Flarsheim IBP Transfer SetPQH · Traditional Liebel-Flarsheim Company, LLC11/18/2020SE
K200280MEDRAD Imaging Bulk Package Transfer SpikePQH · Traditional Bayer Medical Care, Inc.07/30/2020SE
K161723ulrich Transfer SetPQH · Traditional Ulrich GmbH & Co. KG12/21/2016SE
K133147Bracco Injeenering Transfer SetPQH · Traditional Bracco Injeneering S.A.06/20/2014SE

Questions and answers

When was MEDRAD® Imaging Bulk Package Transfer Set cleared by the FDA?

MEDRAD® Imaging Bulk Package Transfer Set (K173913) received a 510(k) decision of Substantially Equivalent on May 4, 2018, 133 days after the submission was received.

What is the product code of K173913?

The FDA product code is PQH – Iodinated Contrast Media Transfer Tubing Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.