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510(k) K802133

Device
BENTLEY THEROMODILUTION CATHETER #BTD-7F
Applicant
BENTLEY LABORATORIES, INC.
510(k) number
K802133
Product code
KRB  
Decision
Substantially Equivalent (SESE)
Decision date
1980-09-26
Date received
1980-09-04
Regulation
870.1915
Classification name
Probe, Thermodilution
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KRB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K171620PiCCO CatheterPulsion Medical Systems SE2018-02-21
K100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLC2010-12-07
K072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESPulsion Medical Systems AG2007-09-19
K020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046Pulsion Medical Systems AG2002-05-23
K991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORPulsion Medical Systems, Inc.2000-05-11
K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITOhmeda Medical1994-03-25
K915627PACEVIEWMicromedical Industries, Ltd.1992-03-27
K912172SAFEWEDGE(TM) RELIEF VALVE DEVICESunscope Intl., Inc.1991-09-27
K902627INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.Biometric Research Institute, Inc.1991-02-25
K900710INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETERIntec Medical, Inc.1990-10-19
K900317PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETERElecath1990-06-22
K892941CCO SYSTEM MODEL SP1467,SP5567,SP6267Spectramed, Inc.1989-11-06
K884318THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEMAbbott Laboratories1988-12-13
K881893NUMED BALLOON THERMODILUTION CATHETERNuMED, Inc.1988-09-06
K874522MODIFIED MYOCARDIAL TEMPERATURE SENSORMon-A-Therm, Inc.1988-01-29

Legacy Summary#

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FDA Review#

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