FDA 510(k)

Ureteral Stent Systems, Biliary Drainage Catheters

K-Number: K191446 · 2020-01-02

Decision Date2020-01-02

Product CodeFAD

Advisory CommitteeGU

DecisionUnknown

Device Summary

Ureteral Stent Systems, Biliary Drainage Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K191446. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Ureteral Stent Systems, Biliary Drainage Catheters?

Ureteral Stent Systems, Biliary Drainage Catheters is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Boston Scientific Corporation. The 510(k) number is K191446.

When did Ureteral Stent Systems, Biliary Drainage Catheters receive FDA 510(k) clearance?

Ureteral Stent Systems, Biliary Drainage Catheters received FDA 510(k) clearance on 2020-01-02, under 510(k) number K191446.

Who is the listed applicant for Ureteral Stent Systems, Biliary Drainage Catheters?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ureteral Stent Systems, Biliary Drainage Catheters?

The FDA product code for Ureteral Stent Systems, Biliary Drainage Catheters is FAD.

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Related Devices (Code: FAD)

K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.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 Corporation K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.