PT2 Guide Wire and Addwire Extension Wire

• 4 recalls, same reason

  • Terminated Z-1538-06 FDA Unclassified (pre-2012) ·initiated 31 Aug 2006
  • Terminated Z-1541-06 FDA Unclassified (pre-2012) ·initiated 31 Aug 2006
  • Terminated Z-1540-06 FDA Unclassified (pre-2012) ·initiated 31 Aug 2006
  • Terminated Z-1539-06 FDA Unclassified (pre-2012) ·initiated 31 Aug 2006

  The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.

510(k) Number

K030617 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

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

• Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery System

  Class II

  FDA 510(k) K000001 Active Cleared 5 Jun 2000

• 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

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