In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath

Catheter, Nephrostomy

Coloplast Corp

The following data is part of a premarket notification filed by Coloplast Corp with the FDA for In-ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath.

Pre-market Notification Details

Device IDK201165
510k NumberK201165
Device Name:In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
ClassificationCatheter, Nephrostomy
Applicant Coloplast Corp 1601 West River Road North Minneapolis,  MN  55411
ContactCori Ragan
CorrespondentSihem Darraji
Coloplast Corp 1601 West River Road North Minneapolis,  MN  55411
Product CodeLJE  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-01
Decision Date2020-12-17

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