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510(k) K924608

Device
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
Applicant
BOSTON SCIENTIFIC CORP.
510(k) number
K924608
Product code
FAD  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-26
Date received
1992-09-11
Regulation
876.4620
Classification name
Stent, Ureteral
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lorraine M Hanley
Address
2710 Orchard Pkwy. San Jose CA US 95134 95134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FAD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.2026-02-20
K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.2025-12-19
K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.2025-06-18
K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.2025-05-14
K250824Percuflex 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 SetBoston Scientific Corporation2025-04-15
K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company2024-03-22
K211934APDL 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, vanSonnenbergBoston Scientific Corporation2022-11-10
K213185ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kitsColoplast Corp.2022-06-08
K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company2022-03-17
K213186NovoFlow Reinforced Ureteral StentColoplast Corp.2022-02-16
K212868JFil Ureteral Stents, JFil Ureteral Stents ECO KITRocamed Sam2022-01-26
K200260Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter SystemBoston Scientific Corporation2021-04-26
K201436Vortek Single Loop Ureteral StentColoplast Corp.2021-02-25
K191446Ureteral Stent Systems, Biliary Drainage CathetersBoston Scientific Corporation2020-01-02
K190659Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed TipAllwin Medical Devices, Inc.2019-12-02

Legacy Summary#

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FDA Review#

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