Cadd-Prizm Model 6100 Pump

• • Terminated Z-0718-2007 FDA Unclassified (pre-2012) ·initiated 19 Jan 2007

  The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm message indicating that the pump requires servicing.

510(k) Number

K960826 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K961580 Active Cleared 20 Sep 1996

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  Class II

  FDA 510(k) K935767 Active Cleared 15 Nov 1995

• Port-A-Cath II Trans-Arterial Percutaneous System

  Class II

  FDA 510(k) K992697 Active Cleared 18 Nov 1999

• Cadd Administration Set, Cadd 250ml Flexible Medication Reservoir, Modified Securit Shell, Security Shell Adapter

  Class II

  FDA 510(k) K990083 Active Cleared 12 Feb 1999

• Port-A-Cath Low-Profile Implantable Access Systems

  Class II

  FDA 510(k) K973862 Active Cleared 29 Dec 1997

• Cadd Administration Set

  Class II

  FDA 510(k) K991599 Active Cleared 15 Jun 1999

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