Swan-Ganz CC0/SVO2 Thermodilution Catheter

• • Terminated Z-1700-2015 FDA Class II ·initiated 5 May 2015

  The product failed to meet the internal established statistical test requirement for heparin activity.

• • Terminated Z-1310-06 FDA Unclassified (pre-2012) ·initiated 21 Jun 2006

  Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user to this situation. This can result in overheating and thermal damage to the CCO catheter and serious patient injury.

510(k) Number

K940795 ↗

FDA Product Code

DYG

Device Class

Class II

Regulation

21 CFR Part 870.1240

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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