Home / Device Classification / KRB

KRB — Probe, Thermodilution Class II

FDA Device Classification

Classification Details

Product Code
KRB
Device Class
Class II
Regulation Number
870.1915
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K171620pulsion medical systems sePiCCO CatheterFebruary 21, 2018
K100739edwards lifesciencesVOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5December 7, 2010
K072364pulsion medical systemsPULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESSeptember 19, 2007
K020587pulsion medical systemsPULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PVMay 23, 2002
K991886pulsion medical systemsPULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOMay 11, 2000
K936182ohmeda medicalCRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITMarch 25, 1994
K915627micromedical industriesPACEVIEWMarch 27, 1992
K912172sunscope intlSAFEWEDGE(TM) RELIEF VALVE DEVICESeptember 27, 1991
K902627biometric research instituteINTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.February 25, 1991
K900710intec medicalINTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETEROctober 19, 1990
K900317elecathPACEMATE FLOW DIRECTED THERMAL DILUTION CATHETERJune 22, 1990
K892941spectramedCCO SYSTEM MODEL SP1467,SP5567,SP6267November 6, 1989
K884318abbott laboratoriesTHERMOSET(TM) CLOSED LOOP DELIVERY SYSTEMDecember 13, 1988
K881893numedNUMED BALLOON THERMODILUTION CATHETERSeptember 6, 1988
K874522mon-a-thermMODIFIED MYOCARDIAL TEMPERATURE SENSORJanuary 29, 1988
K864818ackrad laboratoriesACKRAD TDI SETApril 9, 1987
K843412andover medicalFLOW DIRECTED THERMODILUTION CATH W/VENNovember 20, 1984
K843410andover medicalFLOW-DIRECTED PEDIATRIC THERMODIL- CATHNovember 20, 1984
K840824gouldHEPARIN COATED THERMODILUTION CATHETERSMay 23, 1984
K840992gouldTHERMODILUTION CATHETERMay 23, 1984