KRB · Probe, Thermodilution
Cardiovascular · 21 CFR 870.1915 · Class 2
Overview
| Product Code | KRB |
|---|---|
| Device Name | Probe, Thermodilution |
| Regulation | 21 CFR 870.1915 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 37)
Showing 20 most recent of 37 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K171620 | PiCCO Catheter | Pulsion Medical Systems SE | Feb 21, 2018 | SESE |
| K100739 | VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 | Edwards Lifesciences, LLC | Dec 7, 2010 | SESE |
| K072364 | PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES | Pulsion Medical Systems AG | Sep 19, 2007 | SESE |
| K020587 | PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 | Pulsion Medical Systems AG | May 23, 2002 | SESE |
| K991886 | PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR | Pulsion Medical Systems, Inc. | May 11, 2000 | SESE |
| K936182 | CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT | Ohmeda Medical | Mar 25, 1994 | SESE |
| K915627 | PACEVIEW | Micromedical Industries, Ltd. | Mar 27, 1992 | SESE |
| K912172 | SAFEWEDGE(TM) RELIEF VALVE DEVICE | Sunscope Intl., Inc. | Sep 27, 1991 | SESE |
| K902627 | INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. | Biometric Research Institute, Inc. | Feb 25, 1991 | SESE |
| K900710 | INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER | Intec Medical, Inc. | Oct 19, 1990 | SESE |
| K900317 | PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER | Elecath | Jun 22, 1990 | SESE |
| K892941 | CCO SYSTEM MODEL SP1467,SP5567,SP6267 | Spectramed, Inc. | Nov 6, 1989 | SESE |
| K884318 | THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM | Abbott Laboratories | Dec 13, 1988 | SESE |
| K881893 | NUMED BALLOON THERMODILUTION CATHETER | NuMED, Inc. | Sep 6, 1988 | SESE |
| K874522 | MODIFIED MYOCARDIAL TEMPERATURE SENSOR | Mon-A-Therm, Inc. | Jan 29, 1988 | SESE |
| K864818 | ACKRAD TDI SET | Ackrad Laboratories | Apr 9, 1987 | SESE |
| K843412 | FLOW DIRECTED THERMODILUTION CATH W/VEN | Andover Medical, Inc. | Nov 20, 1984 | SESE |
| K843410 | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH | Andover Medical, Inc. | Nov 20, 1984 | SESE |
| K840992 | THERMODILUTION CATHETER | Gould, Inc. | May 23, 1984 | SESE |
| K840824 | HEPARIN COATED THERMODILUTION CATHETERS | Gould, Inc. | May 23, 1984 | SESE |
Top Applicants
- Gould, Inc. — 4 clearances
- Instrumentation Laboratory CO — 3 clearances
- American Edwards Laboratories — 2 clearances
- Andover Medical, Inc. — 2 clearances
- Edwards Laboratories — 2 clearances
