GUIDANT MEGALINK BILIARY STENT - 1002949-38

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

510(k) Number

K983075 ↗

FDA Product Code

FGE

Models / Variants

#'s 1002949-18

1002949-28

1002949-38

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESU

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See all devices from Guidant Corp. →

• What is the Megalink Biliary Stent used for?

  The Megalink Biliary Stent is designed to maintain patency (open flow) in obstructed or narrowed common bile ducts. It is intended for percutaneous (through-the-skin) placement to facilitate bile drainage, which is critical in treating conditions like bile duct strictures or blockages caused by gallstones or tumors.

• How is the Megalink Biliary Stent supplied and deployed?

  The stent is supplied pre-mounted on a percutaneous transluminal angioplasty (PTA) balloon catheter. Deployment requires inflating the balloon to expand the stent within the bile duct. This ensures precise placement and proper expansion of the stent to restore bile flow.

• Is the Megalink Biliary Stent single-use or reusable?

  The Megalink Biliary Stent is intended for single-use procedures only. This is standard practice for stents to ensure sterility and prevent cross-contamination between patients, as reuse could compromise device integrity and patient safety.

• What materials is the Megalink Biliary Stent made from?

  The stent is constructed from 316L medical-grade stainless steel tubing, a material known for its biocompatibility, durability, and resistance to corrosion, making it suitable for long-term placement within the body.

• What storage conditions should be followed for the Megalink Biliary Stent?

  The available data does not specify detailed storage conditions for the Megalink Biliary Stent. However, as a sterile, single-use device, it should generally be stored in a clean, dry environment away from direct sunlight and extreme temperatures to preserve sterility and functionality until use.