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 Mar 25, 1994
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
K936182
Ohmeda Medical
Cardiovascular · 88d
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 Apr 09, 1987
ACKRAD TDI SET
K864818
Ackrad Laboratories
Cardiovascular · 121d
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 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
Cleared Jul 21, 1976
CATHETER, THERMAL DILUTION, ANIMAL & PED
K760064
Instrumentation Laboratory CO
Cardiovascular · 35d
Cleared Jul 21, 1976
CATHETER, THERMAL DILUTION, PEDIATRIC
K760065
Instrumentation Laboratory CO
Cardiovascular · 35d
Cleared Jul 21, 1976
CATHETER, THERMAL DILUTION, OPEN CHEST
K760067
Instrumentation Laboratory CO
Cardiovascular · 35d

About Product Code KRB - Regulatory Context