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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 a medical device manufactured by Philips Image Guided Therapy Corporation. It received FDA 510(k) clearance on 2020-05-22 under approval 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. It is manufactured by Philips Image Guided Therapy Corporation. The 510(k) number is K200410.

When was Reconnaissance PV .018 OTW Digital IVUS Catheter approved by the FDA?

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

What company makes Reconnaissance PV .018 OTW Digital IVUS Catheter?

Reconnaissance PV .018 OTW Digital IVUS Catheter is manufactured by Philips Image Guided Therapy Corporation.

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 Devices by Philips Image Guided Therapy Corporation

K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) K253714IntraSight Plus PMA P180034Scaffold, dissection repair PMA P230021Stent, iliac vein

Related Devices (Code: OBJ)

K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation K160514OptiCross 18, 30 MHz Peripheral Imaging CatheterBoston Scientific Corporation K161125OptiCross X, 40 MHz Coronary Imaging CatheterBoston Scientific Corporation K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)Boston Scientific Corporation K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)Boston Scientific Corporation

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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