FDA 510(k)

IntraNovo Microcatheter

N.º K: K153125 · 2016-01-13

SolicitanteTexasmedical Technologies, Inc.

Fecha de decisión2016-01-13

Código de productoDQO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

IntraNovo Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Texasmedical Technologies, Inc.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K153125. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the IntraNovo Microcatheter?

IntraNovo Microcatheter is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Texasmedical Technologies, Inc.. The 510(k) number is K153125.

When did IntraNovo Microcatheter receive FDA 510(k) clearance?

IntraNovo Microcatheter received FDA 510(k) clearance on 2016-01-13, under 510(k) number K153125.

Who is the listed applicant for IntraNovo Microcatheter?

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

What is the FDA product code for IntraNovo Microcatheter?

The FDA product code for IntraNovo Microcatheter is DQO.

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Otros registros que enlistan a Texasmedical Technologies, Inc. como solicitante

K170915TXM Hydrophilic Guidewire K170914TXM Support Catheter K153771TXM Guiding Sheath K153703Guiding Catheter

Dispositivos relacionados (Código: DQO)

K261455Conjunto/Plato de Monitoreo de Presión ArterialSpectrum Vascular K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Conjunto/Plato de Monitoreo de Presión ArterialSpectrum Vascular K250751DualView CatheterTerumo Corporation K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC K242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Fuente oficial

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