In-Ka Ureteral Balloon Dilatation Catheter

Dilator, Catheter, Ureteral

Coloplast Corp

The following data is part of a premarket notification filed by Coloplast Corp with the FDA for In-ka Ureteral Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK201007
510k NumberK201007
Device Name:In-Ka Ureteral Balloon Dilatation Catheter
ClassificationDilator, Catheter, Ureteral
Applicant Coloplast Corp 1601 West River Road North Minneapolis,  MN  55411
ContactCori Ragan
CorrespondentCori Ragan
Coloplast Corp 1601 West River Road North Minneapolis,  MN  55411
Product CodeEZN  
CFR Regulation Number876.5470 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-17
Decision Date2020-06-11

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.