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

Catheter, Ultrasound, Intravascular

Philips Image Guided Therapy Corporation

The following data is part of a premarket notification filed by Philips Image Guided Therapy Corporation with the FDA for Verisight Intracardiac Echocardiography (ice) Catheter, Verisight Pro Ice Catheter.

Pre-market Notification Details

Device IDK200812
510k NumberK200812
Device Name:VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter
ClassificationCatheter, Ultrasound, Intravascular
Applicant Philips Image Guided Therapy Corporation 3721 Valley Centre Drive., Suite 500 San Diego,  CA  92130
ContactRand Daoud
CorrespondentRand Daoud
Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell,  WA  98021
Product CodeOBJ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-27
Decision Date2020-09-02

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