FDA 510(k)

Reconnaissance PV .018 OTW Digital IVUS Catheter

N.º K: K200410 · 2020-05-22

SolicitantePhilips Image Guided Therapy Corporation

Fecha de decisión2020-05-22

Código de productoOBJ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Reconnaissance PV .018 OTW Digital IVUS Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Philips Image Guided Therapy Corporation. It received FDA 510(k) clearance on 2020-05-22 under 510(k) number K200410. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Reconnaissance PV .018 OTW Digital IVUS Catheter?

Reconnaissance PV .018 OTW Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2020-05-22. The listed applicant is Philips Image Guided Therapy Corporation. The 510(k) number is K200410.

When did Reconnaissance PV .018 OTW Digital IVUS Catheter receive FDA 510(k) clearance?

Reconnaissance PV .018 OTW Digital IVUS Catheter received FDA 510(k) clearance on 2020-05-22, under 510(k) number K200410.

Who is the listed applicant for Reconnaissance PV .018 OTW Digital IVUS Catheter?

The FDA 510(k) record lists Philips Image Guided Therapy Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reconnaissance PV .018 OTW Digital IVUS Catheter?

The FDA product code for Reconnaissance PV .018 OTW Digital IVUS Catheter is OBJ.

Ensayos clínicos relacionados

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Otros registros que enlistan a Philips Image Guided Therapy Corporation como solicitante

K253714IntraSight Plus K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter

Dispositivos relacionados (Código: OBJ)

K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited K252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston Scientific K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device K250955XC11 ICE System, USAYorlabs, Inc.

Fuente oficial

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