SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER

Catheter, Ultrasound, Intravascular

BIOSENSE WEBSTER

The following data is part of a premarket notification filed by Biosense Webster with the FDA for Soundstar Eco 8f Gultrasound Catheter, Soundstar Eco 8f Ultrasound Catheter.

Pre-market Notification Details

Device IDK140318
510k NumberK140318
Device Name:SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
ClassificationCatheter, Ultrasound, Intravascular
Applicant BIOSENSE WEBSTER 3333 DIAMOND CANYON RD. Baldwin Bar,  CA  91765
ContactMarina Guevrekian
CorrespondentMarina Guevrekian
BIOSENSE WEBSTER 3333 DIAMOND CANYON RD. Baldwin Bar,  CA  91765
Product CodeOBJ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-10
Decision Date2014-03-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10846835008869 K140318 000
10846835008852 K140318 000

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