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Stent, Ureteral

FDA product code FAD · 121 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.4620
Review panel
GU
Implant
Yes
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1978-12-07 – 2026-02-20
FAD 2025-04-15

Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set

Applicant Boston Scientific Corporation

K number K250824

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FAD 2022-11-10

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

K number K211934

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