APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit With Dissolving Tip, Flexima APDL Drainage Catheter System With Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage

Stent, Ureteral

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Apdl Drainage Catheter System, Flexima Apdl Drainage Catheter System, Flexima Apdl Drainage Catheter System Kit With Dissolving Tip, Flexima Apdl Drainage Catheter System With Dissolving Tip, Flexima Apd Drainage Catheter System, Flexima Apd Drainage.

Pre-market Notification Details

Device IDK211934
510k NumberK211934
Device Name:APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit With Dissolving Tip, Flexima APDL Drainage Catheter System With Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage
ClassificationStent, Ureteral
Applicant Boston Scientific Corporation One Scimed Place Maple Grove,  MN  55311
ContactLiz Johnston
CorrespondentLiz Johnston
Boston Scientific Corporation One Scimed Place Maple Grove,  MN  55311
Product CodeFAD  
CFR Regulation Number876.4620 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-22
Decision Date2022-11-10

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