FDA 510(k)

INFINITI™ Ambi Angiographic Catheter

N.º K: K232573 · 2023-11-21

Fecha de decisión2023-11-21

Código de productoDQO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

INFINITI™ Ambi Angiographic Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cordis US Corp. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K232573. 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 INFINITI™ Ambi Angiographic Catheter?

INFINITI™ Ambi Angiographic Catheter is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Cordis US Corp. The 510(k) number is K232573.

When did INFINITI™ Ambi Angiographic Catheter receive FDA 510(k) clearance?

INFINITI™ Ambi Angiographic Catheter received FDA 510(k) clearance on 2023-11-21, under 510(k) number K232573.

Who is the listed applicant for INFINITI™ Ambi Angiographic Catheter?

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

What is the FDA product code for INFINITI™ Ambi Angiographic Catheter?

The FDA product code for INFINITI™ Ambi Angiographic Catheter is DQO.

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Otros registros que enlistan a Cordis US Corp como solicitante

K233637Cordis BRITECROSS Support Catheter K230704RAIN Sheath™ Tibial Pedal Introducer K221832SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation 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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