Modification to Scimed 6F Impulse Angiographic Cathaters

• • Terminated Z-0935-2008 FDA Unclassified (pre-2012) ·initiated 20 Nov 2007

  Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.

510(k) Number

K000956 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

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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