Ivac Nitroglycerin & Lipid Admin. Set Model S75053

• • Terminated Z-1078-2007 FDA Unclassified (pre-2012) ·initiated 5 Jun 2007

  The sterility of the product may be compromised as the packaging used for the sterility barrier was not designed for the sterility process used by the firm.

510(k) Number

K872764 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Infusion Pump

  Class II

  FDA 510(k) K930781 Active Cleared 19 Aug 1993

• Model EZ-1 Sing CHAN/EZ-2 Dual Channel Infus Pump

  Class II

  FDA 510(k) K931549 Active Cleared 12 Oct 1993

• Ivac Syring Pump Model 770

  Class II

  FDA 510(k) K925091 Active Cleared 8 Jul 1993

• Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus Iii Wall Mount Thermometer

  Class II

  FDA 510(k) K955846 Active Cleared 1 Oct 1996

• Ivac Vented Syringe Adapter Administration Sets

  Class II

  FDA 510(k) K934095 Active Cleared 10 Aug 1994

• Ivac Needle Free Valve Administration Sets Open recall

  Class II

  FDA 510(k) K960280 Active Cleared 4 Apr 1996

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