PleurX Peritoneal Catheter System

Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling

CareFusion

The following data is part of a premarket notification filed by Carefusion with the FDA for Pleurx Peritoneal Catheter System.

Pre-market Notification Details

Device IDK201155
510k NumberK201155
Device Name:PleurX Peritoneal Catheter System
ClassificationPeritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Applicant CareFusion 75 North Fairway Drive Vernon Hills,  IL  60061
ContactNazeer Khan
CorrespondentNazeer Khan
CareFusion 75 North Fairway Drive Vernon Hills,  IL  60061
Product CodePNG  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-30
Decision Date2020-10-21

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