FDA 510(k) Applications for Medical Device Product Code "KRB"
(Probe, Thermodilution)

FDA 510(k) Number Applicant Device Name Decision Date
K100739 EDWARDS LIFESCIENCES, LLC. VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 12/07/2010
K020587 PULSION MEDICAL SYSTEMS AG PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 05/23/2002
K072364 PULSION MEDICAL SYSTEMS AG PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES 09/19/2007
K171620 PULSION Medical Systems SE PiCCO Catheter 02/21/2018
K991886 PULSION MEDICAL SYSTEMS, INC. PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR 05/11/2000


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