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FDA 510(k)

Ureteral Stent Systems, Biliary Drainage Catheters

K-Number: K191446 · 2020-01-02

ApplicantBoston Scientific Corporation
Decision Date2020-01-02
Product CodeFAD
Advisory CommitteeGU
DecisionUnknown

Device Summary

Ureteral Stent Systems, Biliary Drainage Catheters is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-01-02 under approval 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. It is manufactured by Boston Scientific Corporation. The 510(k) number is K191446.

When was Ureteral Stent Systems, Biliary Drainage Catheters approved by the FDA?

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

What company makes Ureteral Stent Systems, Biliary Drainage Catheters?

Ureteral Stent Systems, Biliary Drainage Catheters is manufactured by Boston Scientific Corporation.

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.

Related Clinical Trials

NCT07607353 Biodegradable Stents in Primary Sclerosing Cholangitis RECRUITING NCT05546372 Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma RECRUITING NCT05874934 Endoscopic Drainage of Presumed Resectable pCCA Using an Intrahepatic Plastic Stent With Retrieval String COMPLETED NCT07606430 Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction NOT_YET_RECRUITING NCT06750146 Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis SUSPENDED NCT07356284 Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis RECRUITING

Related PubMed Literature

PMID: 25262248 Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration. American heart journal (2014)

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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.

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