Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System

• • Terminated Z-1213-2012 FDA Not yet classified ·initiated 31 Jan 2012

  The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length).

510(k) Number

K093893 ↗

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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