Wing Safe Infusion Set 20 Ga, SHS2000 Series; Wing Safe Infusion Set 19 Ga, SHS1900 Series; Wing Safe Infusion Set 22 Ga

• • Terminated Z-1333-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010

  Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.

510(k) Number

K020544 ↗

FDA Product Code

FPA

Models / Variants

Wing Safe Infusion Set 20 Ga, SHS2000 Series

Wing Safe Infusion Set 19 Ga, SHS1900 Series

Wing Safe Infusion Set 22 Ga

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 30 IV Extension Set W/Two Male Luer Locks

  Class II

  FDA 510(k) K882503 Active Cleared 25 Aug 1988

• Churchill Medical Systems Stopcock

  Class II

  FDA 510(k) K012157 Active Cleared 11 Sep 2001

• Cms IV Filters

  Class II

  FDA 510(k) K896333 Active Cleared 11 Jan 1990

• Universal Vial Access Spike with Needleless Connector

  Class II

  FDA 510(k) K013949 Active Cleared 27 Mar 2002

• CMS IV Extension Sets

  Class II

  FDA 510(k) K884370 Active Cleared 7 Nov 1988

• Modification to 30 Extension Set

  Class II

  FDA 510(k) K021395 Active Cleared 13 May 2002

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