Product code KRB— Cardiovascular
4F STERILE BALLOON-LESS, CATHETER 913-28
- Classification name
- Probe, Thermodilution
- Device class
- Class 2
- Regulation
- 21 CFR 870.1915
- Advisory panel
- Cardiovascular
- Total cleared
- 37
- First cleared
- Most recent
Market context for product code KRB
FDA has cleared devices under product code KRB between 1976 and 2018, filed by 28 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2018
- 2010
- 2007
- 2002
- 2000
- 1994
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1984
- 1983
- 1982
Top applicants under product code KRB
Recent clearances under product code KRB
- K171620 — PiCCO Catheter
- K100739 — VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
- K072364 — PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
- K020587 — PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046
- K991886 — PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
- K936182 — CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
- K915627 — PACEVIEW
- K912172 — SAFEWEDGE(TM) RELIEF VALVE DEVICE
- K902627 — INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.
- K900710 — INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
- K900317 — PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER
- K892941 — CCO SYSTEM MODEL SP1467,SP5567,SP6267
- K884318 — THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
- K881893 — NUMED BALLOON THERMODILUTION CATHETER
- K874522 — MODIFIED MYOCARDIAL TEMPERATURE SENSOR
- K864818 — ACKRAD TDI SET
- K843410 — FLOW-DIRECTED PEDIATRIC THERMODIL- CATH
- K843412 — FLOW DIRECTED THERMODILUTION CATH W/VEN
- K840824 — HEPARIN COATED THERMODILUTION CATHETERS
- K840992 — THERMODILUTION CATHETER
- K830909 — MIKRO-TIP CATH. PRESSURE TRANSDUCER
- K823435 — MON-A-THERM MYOCARDIAL TEMP. SENSOR
- K812800 — FLOW-DIRECTED THERMODILUTION CATHETER
- K811537 — MODEL SP 5507 5-LUMEN THERMODILUTION CAT
- K811411 — SWAN-GANZ HEPARIN COATED, ETC. CATHETER
- K811399 — EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
- K811480 — THERMODILUTION KIT
- K810730 — MODEL SP5107 THERMODILUTION CATHETER
- K802133 — BENTLEY THEROMODILUTION CATHETER #BTD-7F
- K801552 — MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR
- K800836 — KMA FLOW DIRECTED THERMODILUTION CATHETE
- K791873 — USCI SAFE-T-CLOTH THERMODILUTION CAT.
- K791026 — 4F STERILE BALLOON-LESS, CATHETER 913-28
- K771663 — PROBE & CATHETER
- K760064 — CATHETER, THERMAL DILUTION, ANIMAL & PED
- K760065 — CATHETER, THERMAL DILUTION, PEDIATRIC
- K760067 — CATHETER, THERMAL DILUTION, OPEN CHEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.