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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K211934
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 Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
Applicant
Boston Scientific Corporation
One Scimed Place
Maple Grove,  MN  55311
Applicant Contact Liz Johnston
Correspondent
Boston Scientific Corporation
One Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Liz Johnston
Regulation Number876.4620
Classification Product Code
FAD  
Subsequent Product Code
FFA  
Date Received06/22/2021
Decision Date 11/10/2022
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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