KRB · Class II · 21 CFR 870.1915

FDA Product Code KRB: Probe, Thermodilution

Leading manufacturers include Gould, Inc., Instrumentation Laboratory CO and American Edwards Laboratories.

37
Total
37
Cleared
90d
Avg days
1976
Since

FDA 510(k) Cleared Probe, Thermodilution Devices (Product Code KRB)

37 devices
1–24 of 37
Cleared Feb 21, 2018
PiCCO Catheter
K171620
Pulsion Medical Systems SE
Cardiovascular · 264d
Cleared Dec 07, 2010
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
K100739
Edwards Lifesciences, LLC
Cardiovascular · 266d
Cleared Sep 19, 2007
PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
K072364
Pulsion Medical Systems AG
Cardiovascular · 28d
Cleared May 23, 2002
PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046
K020587
Pulsion Medical Systems AG
Cardiovascular · 90d
Cleared May 11, 2000
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
K991886
Pulsion Medical Systems, Inc.
Cardiovascular · 344d
Cleared Mar 25, 1994
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
K936182
Ohmeda Medical
Cardiovascular · 88d
Cleared Oct 19, 1990
INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
K900710
Intec Medical, Inc.
Cardiovascular · 247d
Cleared Dec 13, 1988
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318
Abbott Laboratories
Cardiovascular · 61d
Cleared Sep 06, 1988
NUMED BALLOON THERMODILUTION CATHETER
K881893
NuMED, Inc.
Cardiovascular · 124d
Cleared Jan 29, 1988
MODIFIED MYOCARDIAL TEMPERATURE SENSOR
K874522
Mon-A-Therm, Inc.
Cardiovascular · 88d
Cleared Apr 09, 1987
ACKRAD TDI SET
K864818
Ackrad Laboratories
Cardiovascular · 121d
Cleared Nov 20, 1984
FLOW-DIRECTED PEDIATRIC THERMODIL- CATH
K843410
Andover Medical, Inc.
Cardiovascular · 81d
Cleared Nov 20, 1984
FLOW DIRECTED THERMODILUTION CATH W/VEN
K843412
Andover Medical, Inc.
Cardiovascular · 81d
Cleared May 23, 1984
HEPARIN COATED THERMODILUTION CATHETERS
K840824
Gould, Inc.
Cardiovascular · 89d
Cleared May 23, 1984
THERMODILUTION CATHETER
K840992
Gould, Inc.
Cardiovascular · 77d
Cleared Apr 18, 1983
MIKRO-TIP CATH. PRESSURE TRANSDUCER
K830909
Millar Instruments, Inc.
Cardiovascular · 28d
Cleared Oct 20, 1981
FLOW-DIRECTED THERMODILUTION CATHETER
K812800
Sorensen Research
Cardiovascular · 14d
Cleared Jun 18, 1981
MODEL SP 5507 5-LUMEN THERMODILUTION CAT
K811537
Gould, Inc.
Cardiovascular · 17d
Cleared Jun 12, 1981
SWAN-GANZ HEPARIN COATED, ETC. CATHETER
K811411
American Edwards Laboratories
Cardiovascular · 24d
Cleared Jun 09, 1981
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
K811399
American Edwards Laboratories
Cardiovascular · 21d
Cleared Jun 09, 1981
THERMODILUTION KIT
K811480
American Pharmaseal Div. Ahsc
Cardiovascular · 13d
Cleared Mar 27, 1981
MODEL SP5107 THERMODILUTION CATHETER
K810730
Gould, Inc.
Cardiovascular · 10d
Cleared Sep 26, 1980
BENTLEY THEROMODILUTION CATHETER #BTD-7F
K802133
Bentley Laboratories, Inc.
Cardiovascular · 22d
Cleared Nov 13, 1979
USCI SAFE-T-CLOTH THERMODILUTION CAT.
K791873
C.R. Bard, Inc.
Cardiovascular · 53d

About Product Code KRB - Regulatory Context