FDA 510(k)

MEDRAD® Imaging Bulk Package Transfer Spike

Número K: K253688 · 2026-06-12

Data da decisão2026-06-12

Código do produtoPQH

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Bayer Medical Care, Inc. como candidato(a)

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 K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT

Ver todos os 9 dispositivos →

Dispositivos Relacionados (Código: 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

Fonte oficial

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