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FDA 510(k)

CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set

N.º K: K151048 · 2016-01-22

SolicitanteBracco Injeneering
Fecha de decisión2016-01-22
Código de productoIZQ
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set is the device name listed in this FDA 510(k) record. The listed applicant is Bracco Injeneering. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K151048. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set?

CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Bracco Injeneering. The 510(k) number is K151048.

When did CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set receive FDA 510(k) clearance?

CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set received FDA 510(k) clearance on 2016-01-22, under 510(k) number K151048.

Who is the listed applicant for CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set?

The FDA 510(k) record lists Bracco Injeneering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set?

The FDA product code for CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set is IZQ.

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Dispositivos relacionados (Código: IZQ)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc.K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KGK251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KGK252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG

Fuente oficial

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

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