IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

Shunt, Central Nervous System And Components

IRRAS USA, Ltd.

The following data is part of a premarket notification filed by Irras Usa, Ltd. with the FDA for Irraflow Catheter, Irraflow Tube Set, Irraflow Control Unit.

Pre-market Notification Details

Device IDK192289
501k NumberK192289
Device Name:IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
ClassificationShunt, Central Nervous System And Components
Applicant IRRAS USA, Ltd. 11975 El Camino Real, Suite 304 San Diego,  CA  92130
ContactVinny Podichetty
CorrespondentNiloufa Insanally
IRRAS USA, Ltd. 11975 El Camino Real, 3rd Floor San Diego,  CA  92130
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-23
Decision Date2019-11-15

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.