FDA 510(k)

MEDRAD® Imaging Bulk Package Transfer Set

K-Number: K173913 · 2018-05-04

Decision Date2018-05-04

Product CodePQH

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MEDRAD® Imaging Bulk Package Transfer Set is the device name listed in this FDA 510(k) record. The listed applicant is Bayer U.S., LLC. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K173913. The device is classified under product code PQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD® Imaging Bulk Package Transfer Set?

MEDRAD® Imaging Bulk Package Transfer Set is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Bayer U.S., LLC. The 510(k) number is K173913.

When did MEDRAD® Imaging Bulk Package Transfer Set receive FDA 510(k) clearance?

MEDRAD® Imaging Bulk Package Transfer Set received FDA 510(k) clearance on 2018-05-04, under 510(k) number K173913.

Who is the listed applicant for MEDRAD® Imaging Bulk Package Transfer Set?

The FDA 510(k) record lists Bayer U.S., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDRAD® Imaging Bulk Package Transfer Set?

The FDA product code for MEDRAD® Imaging Bulk Package Transfer Set is PQH.

Related Devices (Code: PQH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253688MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc.K193010Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC K200280MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc.K161723ulrich Transfer SetUlrich GmbH & Co. KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.