FDA 510(k)

Zoom 6F Insert Catheters

N.º K: K233975 · 2024-04-02

Fecha de decisión2024-04-02

Código de productoDQO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Zoom 6F Insert Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2024-04-02 under 510(k) number K233975. 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 Zoom 6F Insert Catheters?

Zoom 6F Insert Catheters is a medical device that received FDA 510(k) clearance on 2024-04-02. The listed applicant is Imperative Care, Inc.. The 510(k) number is K233975.

When did Zoom 6F Insert Catheters receive FDA 510(k) clearance?

Zoom 6F Insert Catheters received FDA 510(k) clearance on 2024-04-02, under 510(k) number K233975.

Who is the listed applicant for Zoom 6F Insert Catheters?

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

What is the FDA product code for Zoom 6F Insert Catheters?

The FDA product code for Zoom 6F Insert Catheters is DQO.

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Otros registros que enlistan a Imperative Care, Inc. como solicitante

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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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