KRB — Probe, Thermodilution Class II
FDA product code KRB covers "Probe, Thermodilution", a Class II medical device regulated under 21 CFR 870.1915. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KRB
- Device Class
- Class II
- Regulation Number
- 870.1915
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K171620 | pulsion medical systems se | PiCCO Catheter | February 21, 2018 |
| K100739 | edwards lifesciences | VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 | December 7, 2010 |
| K072364 | pulsion medical systems | PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES | September 19, 2007 |
| K020587 | pulsion medical systems | PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV | May 23, 2002 |
| K991886 | pulsion medical systems | PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSO | May 11, 2000 |
| K936182 | ohmeda medical | CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT | March 25, 1994 |
| K915627 | micromedical industries | PACEVIEW | March 27, 1992 |
| K912172 | sunscope intl | SAFEWEDGE(TM) RELIEF VALVE DEVICE | September 27, 1991 |
| K902627 | biometric research institute | INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. | February 25, 1991 |
| K900710 | intec medical | INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER | October 19, 1990 |
| K900317 | elecath | PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER | June 22, 1990 |
| K892941 | spectramed | CCO SYSTEM MODEL SP1467,SP5567,SP6267 | November 6, 1989 |
| K884318 | abbott laboratories | THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM | December 13, 1988 |
| K881893 | numed | NUMED BALLOON THERMODILUTION CATHETER | September 6, 1988 |
| K874522 | mon-a-therm | MODIFIED MYOCARDIAL TEMPERATURE SENSOR | January 29, 1988 |
| K864818 | ackrad laboratories | ACKRAD TDI SET | April 9, 1987 |
| K843412 | andover medical | FLOW DIRECTED THERMODILUTION CATH W/VEN | November 20, 1984 |
| K843410 | andover medical | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH | November 20, 1984 |
| K840992 | gould | THERMODILUTION CATHETER | May 23, 1984 |
| K840824 | gould | HEPARIN COATED THERMODILUTION CATHETERS | May 23, 1984 |