Probe, Thermodilution

FDA product code KRB · 37 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1915
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-21 – 2018-02-21

KRB 2018-02-21

PiCCO Catheter

Applicant Pulsion Medical Systems SE

K number K171620

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KRB 2010-12-07

VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5

Applicant Edwards Lifesciences, LLC

K number K100739

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KRB 2007-09-19

PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

Applicant Pulsion Medical Systems AG

K number K072364

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KRB 2002-05-23

PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046

Applicant Pulsion Medical Systems AG

K number K020587

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KRB 2000-05-11

PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR

Applicant Pulsion Medical Systems, Inc.

K number K991886

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KRB 1994-03-25

CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT

Applicant Ohmeda Medical

K number K936182

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KRB 1992-03-27

PACEVIEW

Applicant Micromedical Industries, Ltd.

K number K915627

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KRB 1991-09-27

SAFEWEDGE(TM) RELIEF VALVE DEVICE

Applicant Sunscope Intl., Inc.

K number K912172

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KRB 1991-02-25

INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.

Applicant Biometric Research Institute, Inc.

K number K902627

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KRB 1990-10-19

INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER

Applicant Intec Medical, Inc.

K number K900710

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KRB 1990-06-22

PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER

Applicant Elecath

K number K900317

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KRB 1989-11-06

CCO SYSTEM MODEL SP1467,SP5567,SP6267

Applicant Spectramed, Inc.

K number K892941

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KRB 1988-12-13

THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM

Applicant Abbott Laboratories

K number K884318

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KRB 1988-09-06

NUMED BALLOON THERMODILUTION CATHETER

Applicant NuMED, Inc.

K number K881893

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KRB 1988-01-29

MODIFIED MYOCARDIAL TEMPERATURE SENSOR

Applicant Mon-A-Therm, Inc.

K number K874522

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KRB 1987-04-09

ACKRAD TDI SET

Applicant Ackrad Laboratories

K number K864818

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KRB 1984-11-20

FLOW DIRECTED THERMODILUTION CATH W/VEN

Applicant Andover Medical, Inc.

K number K843412

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KRB 1984-11-20

FLOW-DIRECTED PEDIATRIC THERMODIL- CATH

Applicant Andover Medical, Inc.

K number K843410

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KRB 1984-05-23

THERMODILUTION CATHETER

Applicant Gould, Inc.

K number K840992

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KRB 1984-05-23

HEPARIN COATED THERMODILUTION CATHETERS

Applicant Gould, Inc.

K number K840824

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KRB 1983-04-18

MIKRO-TIP CATH. PRESSURE TRANSDUCER

Applicant Millar Instruments, Inc.

K number K830909

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KRB 1982-12-30

MON-A-THERM MYOCARDIAL TEMP. SENSOR

Applicant Burditt & Calkins-Siemens-Elema

K number K823435

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KRB 1981-10-20

FLOW-DIRECTED THERMODILUTION CATHETER

Applicant Sorensen Research

K number K812800

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KRB 1981-06-18

MODEL SP 5507 5-LUMEN THERMODILUTION CAT

Applicant Gould, Inc.

K number K811537

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KRB 1981-06-12

SWAN-GANZ HEPARIN COATED, ETC. CATHETER

Applicant American Edwards Laboratories

K number K811411

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KRB 1981-06-09

THERMODILUTION KIT

Applicant American Pharmaseal Div. Ahsc

K number K811480

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KRB 1981-06-09

EDSLAB CLOSED INJECTATE DELIVERY SYSTEM

Applicant American Edwards Laboratories

K number K811399

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KRB 1981-03-27

MODEL SP5107 THERMODILUTION CATHETER

Applicant Gould, Inc.

K number K810730

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KRB 1980-09-26

BENTLEY THEROMODILUTION CATHETER #BTD-7F

Applicant Bentley Laboratories, Inc.

K number K802133

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KRB 1980-07-28

MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR

Applicant Edwards Laboratories

K number K801552

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KRB 1980-04-24

KMA FLOW DIRECTED THERMODILUTION CATHETE

Applicant Kma, Inc.

K number K800836

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KRB 1979-11-13

USCI SAFE-T-CLOTH THERMODILUTION CAT.

Applicant C.R. Bard, Inc.

K number K791873

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KRB 1979-06-22

4F STERILE BALLOON-LESS, CATHETER 913-28

Applicant Waters Assoc., Inc.

K number K791026

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KRB 1977-09-20

PROBE & CATHETER

Applicant Edwards Laboratories

K number K771663

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KRB 1976-07-21

CATHETER, THERMAL DILUTION, OPEN CHEST

Applicant Instrumentation Laboratory CO

K number K760067

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KRB 1976-07-21

CATHETER, THERMAL DILUTION, PEDIATRIC

Applicant Instrumentation Laboratory CO

K number K760065

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KRB 1976-07-21

CATHETER, THERMAL DILUTION, ANIMAL & PED

Applicant Instrumentation Laboratory CO

K number K760064

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