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FDA 510(k)

VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter

K-Number: K200812 · 2020-09-02

ApplicantPhilips Image Guided Therapy Corporation
Decision Date2020-09-02
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE 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 2020-09-02 under 510(k) number K200812. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter?

VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Philips Image Guided Therapy Corporation. The 510(k) number is K200812.

When did VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter receive FDA 510(k) clearance?

VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter received FDA 510(k) clearance on 2020-09-02, under 510(k) number K200812.

Who is the listed applicant for VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE 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 VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter?

The FDA product code for VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter is OBJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07552272Hummingbird ICE StudyNOT_YET_RECRUITINGNCT07788040Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access StudyNOT_YET_RECRUITINGNCT07515040Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- GuidanceRECRUITING

Other records listing Philips Image Guided Therapy Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253714IntraSight PlusPMA P230021Stent, iliac veinK251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)PMA P180034Scaffold, dissection repairK200410Reconnaissance PV .018 OTW Digital IVUS Catheter

Related Devices (Code: OBJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision LimitedK252945Novasight 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 ScientificK253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy DeviceK250955XC11 ICE System, USAYorlabs, Inc.K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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