ClearanceBrief
Panels › Cardiovascular › Product code KRB · Class 2

Probe, Thermodilution

Regulation 870.1915

0510(k)s in 12 months (37 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in KRB

Decided510(k)Device and applicantCode
Feb 21, 2018K171620PiCCO Catheter
Pulsion Medical Systems SE, DE
KRB
Dec 7, 2010K100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
Edwards Lifesciences, LLC
KRB
Sep 19, 2007K072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
Pulsion Medical Systems AG
KRB
May 23, 2002K020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046
Pulsion Medical Systems AG
KRB
May 11, 2000K991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
Pulsion Medical Systems, Inc.
KRB
Mar 25, 1994K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
Ohmeda Medical
KRB
Mar 27, 1992K915627PACEVIEW
Micromedical Industries, Ltd.
KRB
Sep 27, 1991K912172SAFEWEDGE(TM) RELIEF VALVE DEVICE
Sunscope Intl., Inc.
KRB
Feb 25, 1991K902627INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.
Biometric Research Institute, Inc.
KRB
Oct 19, 1990K900710INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
Intec Medical, Inc.
KRB
Jun 22, 1990K900317PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER
Elecath
KRB
Nov 6, 1989K892941CCO SYSTEM MODEL SP1467,SP5567,SP6267
Spectramed, Inc.
KRB
Dec 13, 1988K884318THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
Abbott Laboratories
KRB
Sep 6, 1988K881893NUMED BALLOON THERMODILUTION CATHETER
NuMED, Inc.
KRB
Jan 29, 1988K874522MODIFIED MYOCARDIAL TEMPERATURE SENSOR
Mon-A-Therm, Inc.
KRB
Apr 9, 1987K864818ACKRAD TDI SET
Ackrad Laboratories
KRB
Nov 20, 1984K843412FLOW DIRECTED THERMODILUTION CATH W/VEN
Andover Medical, Inc.
KRB
Nov 20, 1984K843410FLOW-DIRECTED PEDIATRIC THERMODIL- CATH
Andover Medical, Inc.
KRB
May 23, 1984K840992THERMODILUTION CATHETER
Gould, Inc.
KRB
May 23, 1984K840824HEPARIN COATED THERMODILUTION CATHETERS
Gould, Inc.
KRB
Apr 18, 1983K830909MIKRO-TIP CATH. PRESSURE TRANSDUCER
Millar Instruments, Inc.
KRB
Dec 30, 1982K823435MON-A-THERM MYOCARDIAL TEMP. SENSOR
Burditt & Calkins-Siemens-Elema
KRB
Oct 20, 1981K812800FLOW-DIRECTED THERMODILUTION CATHETER
Sorensen Research
KRB
Jun 18, 1981K811537MODEL SP 5507 5-LUMEN THERMODILUTION CAT
Gould, Inc.
KRB
Jun 12, 1981K811411SWAN-GANZ HEPARIN COATED, ETC. CATHETER
American Edwards Laboratories
KRB
Jun 9, 1981K811480THERMODILUTION KIT
American Pharmaseal Div. Ahsc
KRB
Jun 9, 1981K811399EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
American Edwards Laboratories
KRB
Mar 27, 1981K810730MODEL SP5107 THERMODILUTION CATHETER
Gould, Inc.
KRB
Sep 26, 1980K802133BENTLEY THEROMODILUTION CATHETER #BTD-7F
Bentley Laboratories, Inc.
KRB
Jul 28, 1980K801552MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR
Edwards Laboratories
KRB
Apr 24, 1980K800836KMA FLOW DIRECTED THERMODILUTION CATHETE
Kma, Inc.
KRB
Nov 13, 1979K791873USCI SAFE-T-CLOTH THERMODILUTION CAT.
C.R. Bard, Inc.
KRB
Jun 22, 1979K7910264F STERILE BALLOON-LESS, CATHETER 913-28
Waters Assoc., Inc.
KRB
Sep 20, 1977K771663PROBE & CATHETER
Edwards Laboratories
KRB
Jul 21, 1976K760067CATHETER, THERMAL DILUTION, OPEN CHEST
Instrumentation Laboratory CO
KRB
Jul 21, 1976K760065CATHETER, THERMAL DILUTION, PEDIATRIC
Instrumentation Laboratory CO
KRB
Jul 21, 1976K760064CATHETER, THERMAL DILUTION, ANIMAL & PED
Instrumentation Laboratory CO
KRB

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