FDA Product Code
FDA Product Code KRB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1915
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K171620 | PiCCO Catheter | Pulsion Medical Systems SE | 2018-02-21 | Traditional | PDF ↗ |
| K100739 | VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 | Edwards Lifesciences, LLC | 2010-12-07 | Traditional | PDF ↗ |
| K072364 | PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES | Pulsion Medical Systems AG | 2007-09-19 | Special | PDF ↗ |
| K020587 | PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 | Pulsion Medical Systems AG | 2002-05-23 | Traditional | PDF ↗ |
| K991886 | PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR | Pulsion Medical Systems, Inc. | 2000-05-11 | Traditional | PDF ↗ |
| K936182 | CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT | Ohmeda Medical | 1994-03-25 | Traditional | PDF ↗ |
| K915627 | PACEVIEW | Micromedical Industries, Ltd. | 1992-03-27 | Traditional | PDF ↗ |
| K912172 | SAFEWEDGE(TM) RELIEF VALVE DEVICE | Sunscope Intl., Inc. | 1991-09-27 | Traditional | PDF ↗ |
| K902627 | INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. | Biometric Research Institute, Inc. | 1991-02-25 | Traditional | PDF ↗ |
| K900710 | INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER | Intec Medical, Inc. | 1990-10-19 | Traditional | PDF ↗ |
| K900317 | PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER | Elecath | 1990-06-22 | Traditional | PDF ↗ |
| K892941 | CCO SYSTEM MODEL SP1467,SP5567,SP6267 | Spectramed, Inc. | 1989-11-06 | Traditional | PDF ↗ |
| K884318 | THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM | Abbott Laboratories | 1988-12-13 | Traditional | PDF ↗ |
| K881893 | NUMED BALLOON THERMODILUTION CATHETER | NuMED, Inc. | 1988-09-06 | Traditional | PDF ↗ |
| K874522 | MODIFIED MYOCARDIAL TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1988-01-29 | Traditional | PDF ↗ |
| K864818 | ACKRAD TDI SET | Ackrad Laboratories | 1987-04-09 | Traditional | PDF ↗ |
| K843410 | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH | Andover Medical, Inc. | 1984-11-20 | Traditional | PDF ↗ |
| K843412 | FLOW DIRECTED THERMODILUTION CATH W/VEN | Andover Medical, Inc. | 1984-11-20 | Traditional | PDF ↗ |
| K840824 | HEPARIN COATED THERMODILUTION CATHETERS | Gould, Inc. | 1984-05-23 | Traditional | PDF ↗ |
| K840992 | THERMODILUTION CATHETER | Gould, Inc. | 1984-05-23 | Traditional | PDF ↗ |
| K830909 | MIKRO-TIP CATH. PRESSURE TRANSDUCER | Millar Instruments, Inc. | 1983-04-18 | Traditional | PDF ↗ |
| K823435 | MON-A-THERM MYOCARDIAL TEMP. SENSOR | Burditt & Calkins-Siemens-Elema | 1982-12-30 | Traditional | PDF ↗ |
| K812800 | FLOW-DIRECTED THERMODILUTION CATHETER | Sorensen Research | 1981-10-20 | Traditional | PDF ↗ |
| K811537 | MODEL SP 5507 5-LUMEN THERMODILUTION CAT | Gould, Inc. | 1981-06-18 | Traditional | PDF ↗ |
| K811411 | SWAN-GANZ HEPARIN COATED, ETC. CATHETER | American Edwards Laboratories | 1981-06-12 | Traditional | PDF ↗ |
| K811480 | THERMODILUTION KIT | American Pharmaseal Div. Ahsc | 1981-06-09 | Traditional | PDF ↗ |
| K811399 | EDSLAB CLOSED INJECTATE DELIVERY SYSTEM | American Edwards Laboratories | 1981-06-09 | Traditional | PDF ↗ |
| K810730 | MODEL SP5107 THERMODILUTION CATHETER | Gould, Inc. | 1981-03-27 | Traditional | PDF ↗ |
| K802133 | BENTLEY THEROMODILUTION CATHETER #BTD-7F | Bentley Laboratories, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K801552 | MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR | Edwards Laboratories | 1980-07-28 | Traditional | PDF ↗ |
| K800836 | KMA FLOW DIRECTED THERMODILUTION CATHETE | Kma, Inc. | 1980-04-24 | Traditional | PDF ↗ |
| K791873 | USCI SAFE-T-CLOTH THERMODILUTION CAT. | C.R. Bard, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K791026 | 4F STERILE BALLOON-LESS, CATHETER 913-28 | Waters Assoc., Inc. | 1979-06-22 | Traditional | PDF ↗ |
| K771663 | PROBE & CATHETER | Edwards Laboratories | 1977-09-20 | Traditional | PDF ↗ |
| K760065 | CATHETER, THERMAL DILUTION, PEDIATRIC | Instrumentation Laboratory CO | 1976-07-21 | Traditional | PDF ↗ |
| K760064 | CATHETER, THERMAL DILUTION, ANIMAL & PED | Instrumentation Laboratory CO | 1976-07-21 | Traditional | PDF ↗ |
| K760067 | CATHETER, THERMAL DILUTION, OPEN CHEST | Instrumentation Laboratory CO | 1976-07-21 | Traditional | PDF ↗ |
Product code KRB · Class II · Cardiovascular. Data: openFDA.