Lifestent LP Sds Biliary Endoprosthesis

• • Terminated Z-1075-04 FDA Unclassified (pre-2012) ·initiated 19 Mar 2004 ·on shared 510(k) K023248

  BALLOONS HAVE LONGER THAN EXPECTED DEFLATION TIMES.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K023248 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESU

• Lifestent Sds Biliary Endoprosthesis, Lifestent Xl Sds Biliary Endoprosthesis

  Class II

  FDA 510(k) K023308 Active Cleared 14 Apr 2003

• Lifestent Biliary Endoprosthesis

  Class II

  FDA 510(k) K023121 Active Cleared 10 Mar 2003

• Lifestent Sds Biliary Endoprosthesis

  Class II

  FDA 510(k) K033212 Active Cleared 30 Oct 2003

• Lifestent LP Sds Biliary Endoprosthesis

  Class II

  FDA 510(k) K041370 Active Cleared 24 Jun 2004

• R Stent Biliary Endoprosthesis

  Class II

  FDA 510(k) K010107 Active Cleared 31 Jul 2001

• Lifestent Sds and Xl Sds Biliary Endoprosthesis

  Class II

  FDA 510(k) K040550 Active Cleared 16 Mar 2004

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