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FDA 510(k)

Reconnaissance PV .018 OTW Digital IVUS Catheter

K-Number: K200410 · 2020-05-22

ApplicantPhilips Image Guided Therapy Corporation
Decision Date2020-05-22
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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 repairK200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE 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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