Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus

Catheter, Straight

ConvaTec, Inc.

The following data is part of a premarket notification filed by Convatec, Inc. with the FDA for Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus.

Pre-market Notification Details

Device IDK221593
510k NumberK221593
Device Name:Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
ClassificationCatheter, Straight
Applicant ConvaTec, Inc. 7815 National Service Road, Suite 600 Greensboro,  NC  27409
ContactCourtney Smith
CorrespondentDawn Norman
MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial,  CO  80112
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-02
Decision Date2022-11-17

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