EQUINOX Balloon Dilatation Catheter

Dilator, Catheter, Ureteral

Dornier MedTech America Inc

The following data is part of a premarket notification filed by Dornier Medtech America Inc with the FDA for Equinox Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK190612
510k NumberK190612
Device Name:EQUINOX Balloon Dilatation Catheter
ClassificationDilator, Catheter, Ureteral
Applicant Dornier MedTech America Inc 1155 Roberts Blvd, Suite 100 Kennesaw,  GA  30144
ContactJohn Hoffer
CorrespondentJohn Hoffer
Dornier MedTech America Inc 1155 Roberts Blvd, Suite 100 Kennesaw,  GA  30144
Product CodeEZN  
CFR Regulation Number876.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-11
Decision Date2019-12-06

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