ImaJin Silicone Double Loop Ureteral Stent Kits, ImaJin Pyelostent Silicone Double Loop Ureteral Stent Kits, ImaJin Stenostent Silicone Double Loop Ureteral Stent Kits

Stent, Ureteral

Coloplast Corp

The following data is part of a premarket notification filed by Coloplast Corp with the FDA for Imajin Silicone Double Loop Ureteral Stent Kits, Imajin Pyelostent Silicone Double Loop Ureteral Stent Kits, Imajin Stenostent Silicone Double Loop Ureteral Stent Kits.

Pre-market Notification Details

Device IDK213185
510k NumberK213185
Device Name:ImaJin Silicone Double Loop Ureteral Stent Kits, ImaJin Pyelostent Silicone Double Loop Ureteral Stent Kits, ImaJin Stenostent Silicone Double Loop Ureteral Stent Kits
ClassificationStent, Ureteral
Applicant Coloplast Corp 1601 West River Road North Minneapolis,  MN  55411
ContactGayatri Ghadge
CorrespondentGayatri Ghadge
Coloplast Corp 1601 West River Road North Minneapolis,  MN  55411
Product CodeFAD  
CFR Regulation Number876.4620 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-29
Decision Date2022-06-08

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