FDA 510(k)

MEDRAD® Imaging Bulk Package Transfer Spike

K-Number: K253688 · 2026-06-12

Decision Date2026-06-12

Product CodePQH

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MEDRAD® Imaging Bulk Package Transfer Spike is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K253688. 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 Spike?

MEDRAD® Imaging Bulk Package Transfer Spike is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K253688.

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

MEDRAD® Imaging Bulk Package Transfer Spike received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253688.

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

The FDA 510(k) record lists Bayer Medical Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Bayer Medical Care, Inc. as applicant

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.

K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)K250893Ball Joint Guide Array (66295)K200280MEDRAD Imaging Bulk Package Transfer Spike K192370MEDRAD Stellant FLEX CT Injection System with Certegra Workstation K193028MEDRAD Mark 7 Arterion Injection System K182276MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit

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Related Devices (Code: PQH)

K193010Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC K200280MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc.K173913MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC 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.