Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery System

• • Terminated Z-2833-2011 FDA Unclassified (pre-2012) ·initiated 25 May 2011

  Boston Scientific is initiating an important field correction related to WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis products. This letter is intended to clarify and re-emphasize that U.S. WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis stents are NOT currently cleared by the FDA for use in benign tracheobronchial strictures.

510(k) Number

K000001 ↗

FDA Product Code

JCT

Device Class

Class II

Regulation

21 CFR Part 878.3720

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Niroyal Biliary Premounted Stent System

  Class II

  FDA 510(k) K012216 Active Cleared 17 Aug 2001

• Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System

  Class II

  FDA 510(k) K993232 Active Cleared 30 Dec 1999

• Schneider Guidezilla Softip Guiding Catheter

  Class II

  FDA 510(k) K935292 Active Cleared 10 Jun 1994

• Walstent Tracheobronchial Endoprosthesis

  Class II

  FDA 510(k) K961507 Active Cleared 10 Jul 1996

• Wallstent Tracheobronchial Endoprosthesis

  Class II

  FDA 510(k) K961296 Active Cleared 10 Jul 1996

• Wallstent Enteral Endoprosthesis

  Class II

  FDA 510(k) K980113 Active Cleared 3 Apr 1998

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