Medical Device Manufacturer · US , Mchenry , IL

Critikon Company, LLC - FDA 510(k) Cleared Devices

51 submissions · 51 cleared · Since 1979
51
Total
51
Cleared
0
Denied
FDA 510(k) Regulatory Record - Critikon Company, LLC General Hospital
19 devices
1-19 of 19
Cleared Dec 14, 1993
CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
K933050 · FOZ
General Hospital · 208d
Cleared Jun 03, 1991
RATEMINDER(TM) V INFUSION PUMP, MODIFICATION
K911769 · FRN
General Hospital · 45d
Cleared Jul 26, 1990
RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY
K902092 · FRN
General Hospital · 78d
Cleared Nov 01, 1989
OPTICALLY CLEAR RADIOPAQUE CATHETER
K893546 · FOZ
General Hospital · 174d
Cleared May 11, 1988
SIM MODULE
K874546 · FRN
General Hospital · 190d
Cleared Mar 29, 1988
RATEMINDER V INFUSION PUMP
K875174 · FRN
General Hospital · 103d
Cleared Jan 14, 1988
J&J SCALP VEIN INFUSION SETS
K875177 · FOZ
General Hospital · 23d
Cleared Dec 29, 1987
RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET
K873729 · FPA
General Hospital · 105d
Cleared Jul 22, 1986
CRITIKON 48-HOUR AIR ELIMINATING FILTER
K861644 · FPB
General Hospital · 83d
Cleared Oct 17, 1985
JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL
K853701 · FOZ
General Hospital · 43d
Cleared Mar 07, 1985
CRITIKON I.V. ADMINISTRAION SET
K850507 · FPA
General Hospital · 27d
Cleared Jun 28, 1984
CRITIKON I.V. FILTER
K842075 · FPB
General Hospital · 36d
Cleared Feb 21, 1984
NITROGLYCERIN I.V. ADMINISTRATION SET
K833939 · FPA
General Hospital · 98d
Cleared Aug 12, 1983
SIMPLICITY PLUS
K831761 · FRN
General Hospital · 72d
Cleared Apr 27, 1983
I.V. CATHETER PLACEMENT UNIT POLYURETH
K830972 · FOZ
General Hospital · 30d
Cleared Jan 12, 1982
CRITIKON I.V. CATHETER PLACEMENT UNIT
K813345 · FOZ
General Hospital · 48d
Cleared Jun 12, 1981
IV SETS
K811107 · FPA
General Hospital · 50d
Cleared Jan 28, 1981
SIMPLICITY INFUSION PUMP MODEL 2100A
K803078 · FRN
General Hospital · 54d
Cleared Aug 27, 1980
THE SIMPLICITY PUMP #2100 INFUSION PUMP
K801546 · FRN
General Hospital · 51d
Filters