FDA 510(k)

GORE Molding and Occlusion Balloon Catheter

N.º K: K172567 · 2018-01-31

SolicitanteW. L. Gore and Associates, Inc.

Fecha de decisión2018-01-31

Código de productoMJN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

GORE Molding and Occlusion Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore and Associates, Inc.. It received FDA 510(k) clearance on 2018-01-31 under 510(k) number K172567. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the GORE Molding and Occlusion Balloon Catheter?

GORE Molding and Occlusion Balloon Catheter is a medical device that received FDA 510(k) clearance on 2018-01-31. The listed applicant is W. L. Gore and Associates, Inc.. The 510(k) number is K172567.

When did GORE Molding and Occlusion Balloon Catheter receive FDA 510(k) clearance?

GORE Molding and Occlusion Balloon Catheter received FDA 510(k) clearance on 2018-01-31, under 510(k) number K172567.

Who is the listed applicant for GORE Molding and Occlusion Balloon Catheter?

The FDA 510(k) record lists W. L. Gore and Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE Molding and Occlusion Balloon Catheter?

The FDA product code for GORE Molding and Occlusion Balloon Catheter is MJN.

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Otros registros que enlistan a W. L. Gore and Associates, Inc. como solicitante

K250410GORE® Tri-Lobe Balloon Catheter K240083GORE® PROPATEN® Vascular Graft K232312GORE® PROPATEN® Vascular Graft K233551GORE® ACUSEAL Vascular Graft K231505GORE® ACUSEAL Vascular Graft K222919GORE® ENFORM Biomaterial

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Dispositivos relacionados (Código: MJN)

K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy Devices K221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLC K212324RenovoCathRenovorx, Inc.

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.