Product code KRB
- Device name
- Probe, Thermodilution
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1915
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171620 | PiCCO Catheter | Pulsion Medical Systems SE | 2018-02-21 |
| K100739 | VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 | Edwards Lifesciences, LLC | 2010-12-07 |
| K072364 | PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES | Pulsion Medical Systems AG | 2007-09-19 |
| K020587 | PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 | Pulsion Medical Systems AG | 2002-05-23 |
| K991886 | PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR | Pulsion Medical Systems, Inc. | 2000-05-11 |
| K936182 | CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT | Ohmeda Medical | 1994-03-25 |
| K915627 | PACEVIEW | Micromedical Industries, Ltd. | 1992-03-27 |
| K912172 | SAFEWEDGE(TM) RELIEF VALVE DEVICE | Sunscope Intl., Inc. | 1991-09-27 |
| K902627 | INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. | Biometric Research Institute, Inc. | 1991-02-25 |
| K900710 | INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER | Intec Medical, Inc. | 1990-10-19 |
| K900317 | PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER | Elecath | 1990-06-22 |
| K892941 | CCO SYSTEM MODEL SP1467,SP5567,SP6267 | Spectramed, Inc. | 1989-11-06 |
| K884318 | THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM | Abbott Laboratories | 1988-12-13 |
| K881893 | NUMED BALLOON THERMODILUTION CATHETER | NuMED, Inc. | 1988-09-06 |
| K874522 | MODIFIED MYOCARDIAL TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1988-01-29 |
| K864818 | ACKRAD TDI SET | Ackrad Laboratories | 1987-04-09 |
| K843412 | FLOW DIRECTED THERMODILUTION CATH W/VEN | Andover Medical, Inc. | 1984-11-20 |
| K843410 | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH | Andover Medical, Inc. | 1984-11-20 |
| K840992 | THERMODILUTION CATHETER | Gould, Inc. | 1984-05-23 |
| K840824 | HEPARIN COATED THERMODILUTION CATHETERS | Gould, Inc. | 1984-05-23 |
| K830909 | MIKRO-TIP CATH. PRESSURE TRANSDUCER | Millar Instruments, Inc. | 1983-04-18 |
| K823435 | MON-A-THERM MYOCARDIAL TEMP. SENSOR | Burditt & Calkins-Siemens-Elema | 1982-12-30 |
| K812800 | FLOW-DIRECTED THERMODILUTION CATHETER | Sorensen Research | 1981-10-20 |
| K811537 | MODEL SP 5507 5-LUMEN THERMODILUTION CAT | Gould, Inc. | 1981-06-18 |
| K811411 | SWAN-GANZ HEPARIN COATED, ETC. CATHETER | American Edwards Laboratories | 1981-06-12 |
| K811480 | THERMODILUTION KIT | American Pharmaseal Div. Ahsc | 1981-06-09 |
| K811399 | EDSLAB CLOSED INJECTATE DELIVERY SYSTEM | American Edwards Laboratories | 1981-06-09 |
| K810730 | MODEL SP5107 THERMODILUTION CATHETER | Gould, Inc. | 1981-03-27 |
| K802133 | BENTLEY THEROMODILUTION CATHETER #BTD-7F | Bentley Laboratories, Inc. | 1980-09-26 |
| K801552 | MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR | Edwards Laboratories | 1980-07-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08886483551664 | Safewedge(TM) Relief Valve Device | BIOPTIMAL INTERNATIONAL PTE. LTD. | 2026-05-20 |
| 27325710017061 | PiCCO catheter | Maquet Critical Care AB | 2026-03-24 |
| 27325710017108 | PiCCO catheter | Maquet Critical Care AB | 2026-03-24 |
| 27325710017092 | PiCCO catheter | Maquet Critical Care AB | 2026-03-24 |
| 27325710017047 | PiCCO catheter | Maquet Critical Care AB | 2026-03-24 |
| 27325710011601 | PiCCO catheter | Maquet Critical Care AB | 2026-03-24 |
| 27325710011144 | ITS Housing | Maquet Critical Care AB | 2026-03-24 |
| 00690103000078 | CO-SET INJECTATE ICE BUCKET | Edwards Lifesciences LLC | 2025-07-16 |
| 00195278522313 | CARESCAPE Canvas Smart Display | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278522320 | CARESCAPE Canvas 1000 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278523365 | CARESCAPE Canvas D19 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278524089 | NA | GE Healthcare Finland Oy | 2023-04-19 |
| 00840619043636 | ICU Medical | ICU MEDICAL, INC. | 2021-10-19 |
| 00840619044121 | ICU Medical | ICU MEDICAL, INC. | 2021-08-29 |
| 00840619044145 | ICU Medical | ICU MEDICAL, INC. | 2021-08-29 |
| 10884450557102 | Critikit™ | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2021-03-08 |
| 10884450320904 | Critikit™ | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2018-01-30 |
| 10884450320911 | Critikit™ | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2018-01-30 |
| 20884838072248 | Spirometry Sensor | Philips Medizin Systeme Böblingen GmbH | 2017-01-20 |
| 00840682104425 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104432 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104449 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104456 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104463 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682103930 | CARESCAPE | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | 2016-06-03 |
| 00840682103978 | NA | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682103992 | NA | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682105118 | CARESCAPE | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682105200 | CARESCAPE | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682105224 | CARESCAPE | GE Healthcare Finland Oy | 2016-06-03 |