Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tria Firm Ureteral Stent

K-Number: K163399 · 2017-06-22

ApplicantBoston Scientific Corporation
Decision Date2017-06-22
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Tria Firm Ureteral Stent is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-06-22 under approval number K163399. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tria Firm Ureteral Stent?

Tria Firm Ureteral Stent is a medical device that received FDA 510(k) clearance on 2017-06-22. It is manufactured by Boston Scientific Corporation. The 510(k) number is K163399.

When was Tria Firm Ureteral Stent approved by the FDA?

Tria Firm Ureteral Stent received FDA 510(k) clearance on 2017-06-22, under approval number K163399.

What company makes Tria Firm Ureteral Stent?

Tria Firm Ureteral Stent is manufactured by Boston Scientific Corporation.

What is the FDA product code for Tria Firm Ureteral Stent?

The FDA product code for Tria Firm Ureteral Stent is FAD.

Related Clinical Trials

NCT04674969 Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature RECRUITING NCT04200937 IT Matters: The Erectile Restoration Registry ENROLLING_BY_INVITATION NCT07580963 Stent Related Symptoms Defined by Ureteral Stent Symptom Questionnaire in Patients With Image-Informed Ureteral Stent Lengths NOT_YET_RECRUITING NCT02686125 Vercise™ DBS Dystonia Prospective Study RECRUITING NCT04032470 Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET) RECRUITING NCT03735667 ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement ACTIVE_NOT_RECRUITING

Other Devices by Boston Scientific Corporation

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete K163174Emerge PTCA Dilatation Catheter K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 K162404Express SD Biliary Monorail Premounted Stent System K160823NC Quantum Apex PTCA Dilatation Catheter K160514OptiCross 18, 30 MHz Peripheral Imaging Catheter

View all 176 devices →

Related Devices (Code: FAD)

K163068pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation K161277ConvertX Nephroureteral Stent SystemBrightwater Medical K160891Ultrathane Endoureterotomy Stent SetCook Incorporated K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTSColoplast Corp. K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTSColoplast Corp.

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.

↑