Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary Systems

• • Terminated Z-1550-2013 FDA Class II ·initiated 29 May 2012

  There was an error on the outer labeling of this device. The inner label was correct.

510(k) Number

K111766 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESU

• Supera Veritas(R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System

  Class II

  FDA 510(k) K111627 Active Cleared 21 Aug 2012

• Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model # S-04-040-120

  Class II

  FDA 510(k) K071646 Active Cleared 31 Jan 2008

• Akonya Eliminator Mechanical Thrombectomy Device, Model El 10060060

  Class II

  FDA 510(k) K030504 Active Cleared 16 Sep 2003

• Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System

  Class II

  FDA 510(k) K122546 Active Cleared 7 Dec 2012

• Supera Veritas

  Class II

  FDA 510(k) K130591 Active Cleared 2 May 2013

• Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060

  Class II

  FDA 510(k) K041374 Active Cleared 2 Mar 2005

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