FDA 510(k)

MEDRAD Imaging Bulk Package Transfer Spike

N.º K: K200280 · 2020-07-30

Fecha de decisión2020-07-30

Código de productoPQH

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del 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 2020-07-30 under 510(k) number K200280. The device is classified under product code PQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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 2020-07-30. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K200280.

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 2020-07-30, under 510(k) number K200280.

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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Otros registros que enlistan a Bayer Medical Care, Inc. como solicitante

K253688MEDRAD® Imaging Bulk Package Transfer Spike K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)K250893Ball Joint Guide Array (66295)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 los 9 dispositivos →

Dispositivos relacionados (Código: PQH)

K253688MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc.K193010Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC K173913MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC K161723ulrich Transfer SetUlrich GmbH & Co. KG

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.