Bridge Se Self-Expanding Stent Delivery System

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

510(k) Number

K011080 ↗

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

• Aurora Biliary Stent System

  Class II

  FDA 510(k) K030839 Active Cleared 30 May 2003

• 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 is the Bridge Se Stent Delivery System used for?

  The Bridge Se Stent Delivery System is designed for use in the biliary ducts.

• Is the Bridge Se Stent Delivery System a single-use device?

  Yes, the Bridge Se Stent Delivery System is a single-use device.

• What are the available sizes and models of the Bridge Se Stent Delivery System?

  The device has various sizes and models, but exact details are not specified in the provided data.