Aurora Biliary Stent System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Medtronic Ave Bridge Aurora Biliary Stent System (Aurora)

510(k) Number

K030839 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESU

• Medtronic, Inc. Racer Biliary Stent System (Racer), Model Xd#yf(L)

  Class II

  FDA 510(k) K032768 Active Cleared 9 Oct 2003

• Bridge Se Self-Expanding Stent Delivery System

  Class II

  FDA 510(k) K011080 Active Cleared 11 Oct 2001

• Medtronic Ave Bridge Constant Biliary Stent System

  Class II

  FDA 510(k) K030633 Active Cleared 2 Sep 2003

• Wire, Guide, Catheter, Model QSW1000

  Class II

  FDA 510(k) K002346 Active Cleared 27 Sep 2000

• Bridge Fx

  Class II

  FDA 510(k) K011817 Active Cleared 22 Aug 2001

• Medtronic Ave Bridge X3 Stent

  Class II

  FDA 510(k) K000744 Active Cleared 5 Jun 2000

See all devices from Medtronic Ave, Inc. →

• What clinical scenarios is the Aurora Biliary Stent System intended to address specifically within biliary drainage procedures?

  The Aurora Biliary Stent System is designed to palliate obstructions caused by malignant neoplasms (cancers) within the biliary tree, which are the ducts responsible for transporting bile from the liver to the small intestine. It is intended for biliary duct drainage to relieve blockages that can lead to conditions like cholestasis or jaundice in patients with malignant biliary strictures.

• How is the Aurora Biliary Stent System delivered, and what type of procedural setting is it intended for?

  The Aurora Biliary Stent System is delivered transhepatically via a sheathed delivery catheter, meaning it is inserted through the liver into the biliary ducts. It is intended for use in clinical settings such as endoscopy or interventional radiology, where fluoroscopic guidance is available to assist with precise placement.

• Is the Aurora Biliary Stent System reusable, or is it intended for single-use only?

  The Aurora Biliary Stent System is explicitly intended for single-use only, as stated in its design and regulatory documentation. This ensures patient safety and sterility, as it is supplied sterile and not meant to be reused.

• What materials is the Aurora Biliary Stent System constructed from, and why does this matter?

  The Aurora Biliary Stent System is constructed from biocompatible materials, which means they are designed to be safe for use within the human body without causing adverse reactions. This is particularly important for long-term drainage applications, as biocompatibility reduces the risk of inflammation, infection, or other complications.

• What regulatory pathway was followed for the Aurora Biliary Stent System, and what does this mean for its use?

  The Aurora Biliary Stent System was cleared through the FDA’s 510(k) pathway, specifically under clearance number K030839, and is classified as a Class II device under regulation number 876.5010. This means it has undergone a premarket submission process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for its intended use in biliary drainage.