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510(k) K190603

Tria Firm Ureteral Stent by Boston Scientific Corporation — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2019
Date Received
March 8, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

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  • K211934 — APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima AP (November 10, 2022)
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