Liebel-Flarsheim IBP Transfer Set

FDA 510(k) K193010 · Liebel-Flarsheim Company, LLC

Substantially Equivalent

510(k) numberK193010

Submission

Device name
Liebel-Flarsheim IBP Transfer Set
Applicant
Liebel-Flarsheim Company, LLC
Richmond Heights, MO, US
Received
October 29, 2019
Decision date
November 18, 2020
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
K200280MEDRAD Imaging Bulk Package Transfer SpikePQH · Traditional Bayer Medical Care, Inc.07/30/2020SE
K173913MEDRAD® Imaging Bulk Package Transfer SetPQH · Traditional Bayer U.S., LLC05/04/2018SE
K161723ulrich Transfer SetPQH · Traditional Ulrich GmbH & Co. KG12/21/2016SE
K133147Bracco Injeenering Transfer SetPQH · Traditional Bracco Injeneering S.A.06/20/2014SE

More from Bracco Injeneering S.A.

510(k)DeviceDecision
K152361OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling…IZQ · Traditional 01/14/2016SE
K121838Liebel-Flarsheim Direct Digital Imaging SystemMQB · Traditional 07/11/2012SE

Questions and answers

When was Liebel-Flarsheim IBP Transfer Set cleared by the FDA?

Liebel-Flarsheim IBP Transfer Set (K193010) received a 510(k) decision of Substantially Equivalent on November 18, 2020, 386 days after the submission was received.

What is the product code of K193010?

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