Park Blade Septostomy Catheter

Catheter, Septostomy

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Park Blade Septostomy Catheter.

Pre-market Notification Details

Device IDK182399
510k NumberK182399
Device Name:Park Blade Septostomy Catheter
ClassificationCatheter, Septostomy
Applicant Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
ContactRebecca Odulio
CorrespondentRebecca Odulio
Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
Product CodeDXF  
CFR Regulation Number870.5175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-04
Decision Date2019-04-04

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