Cobe Laboratories, Inc.
Medical device manufacturer in Arvada, CO.
77510(k) clearances
0PMA approvals
0recalls
Device types
- FJI Dialyzer, Capillary, Hollow Fiber 6
- DTZ Oxygenator, Cardiopulmonary Bypass 6
- FJG Dialyzer, Parallel Flow 4
- FKP System, Dialysate Delivery, Single Patient 4
- DTN Reservoir, Blood, Cardiopulmonary Bypass 3
- DTQ Console, Heart-Lung Machine… 3
- DTR Heat-Exchanger, Cardiopulmonary Bypass 3
- KDI Dialyzer, High Permeability With Or Without… 2
- DSY Prosthesis, Vascular Graft, Of 6mm And… 2
- LKN Separator, Automated, Blood Cell And… 2
- CAC Apparatus, Autotransfusion 2
- KRL Detector, Bubble, Cardiopulmonary Bypass 2
- DTM Filter, Blood, Cardiopulmonary Bypass… 2
- JOD Filter, Blood, Cardiotomy Suction Line… 2
- DTL Adaptor, Stopcock, Manifold, Fitting… 2
- DWF Catheter, Cannula And Tubing, Vascular… 2
- KOC Accessories, Blood Circuit, Hemodialysis 2
- GKF Instrument, Hematocrit, Automated 1
- DQO Catheter, Intravascular, Diagnostic 1
- FJF Detector, Air Bubble 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K923272 | Cobe Cms-Hf Hollow Fiber Membrane OxygenatorDTZ · Traditional | 05/11/1993SE |
| K900105 | Cobe Spectra Blood Component Separator TherapeuticLKN · Traditional | 03/22/1991SE |
| K905793 | Cobe Centry 2 Bicart Option KitFKP · Traditional | 02/12/1991SE |
| K905388 | Cobe Centrysystem 3 Bicart Option KitFKP · Traditional | 02/11/1991SE |
| K904336 | New Cobe Saturation/Hematocrit MonitorGKF · Traditional | 12/27/1990SE |
| K902631 | Cobe ICU Conversion KitDTN · Traditional | 12/17/1990SE |
| K902437 | Cobe Cardiotomy Reservoir with or Without FilterDTP · Traditional | 12/17/1990SE |
| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | 12/12/1990SE |
| K902758 | Cobe Saturation/Hematocrit Monitor W/ Fiber OpticDQA · Traditional | 08/23/1990SE |
| K902759 | Cobe Closed Wound Drainage KitCAC · Traditional | 07/18/1990SE |
| K902671 | Cobe Autologous Blood Salvage Reserv W/W/O FilterCAC · Traditional | 07/17/1990SE |
| K900910 | Cobe Air Emboli Protection System (Aeps)DTW · Traditional | 05/22/1990SE |
| K900758 | Heparinized Arterial Screen Blood FilterDTM · Traditional | 05/17/1990SE |
| K895076 | CMS VRB-1200DTN · Traditional | 11/03/1989SE |
| K893962 | Cobe 2991 Supplementary Disposable SetsLKN · Traditional | 10/18/1989SE |
| K881811 | Cobe Centrysystem Hollow Fiber DialyzersFJI · Traditional | 09/15/1988SE |
| K881330 | Cobe Heart/Lung Perfusion and Cardioplegia PackDWF · Traditional | 06/10/1988SE |
| K881062 | Centry 2 Ultrafiltration Control Kit, #018762-002FJB · Traditional | 04/21/1988SE |
| K880021 | Cobe CML3DTZ · Traditional | 04/01/1988SE |
| K870976 | Onguard 1000, Catalog #043611-000 & 043611-001DTQ · Traditional | 05/06/1987SE |
| K864831 | Cobe Centrysystem 145E,160E,175E,190E DialyzersFJI · Traditional | 03/27/1987SE |
| K861808 | Vascutek Vascular Prostheses, Extra Soft/Low WovenDSY · Traditional | 09/15/1986SE |
| K861860 | Cobe Accessory Interface Module (Aim)KRL · Traditional | 07/18/1986SE |
| K855064 | Swank Blood Transfusion Micro-Filter W/Straight SeCAK · Traditional | 03/12/1986SE |
| K855065 | Prevent 0.2 Micron IV Filter W/Vent & Extension SeFPB · Traditional | 02/28/1986SE |
| K855067 | Swank Cardiotomy Suction Line Blood Filter CA100JOD · Traditional | 02/26/1986SE |
| K855066 | Swank Arterial Line Blood Filter HF6000DTM · Traditional | 02/26/1986SE |
| K853101 | Vascuter External Reinforce Triaxial ProsthesesDSY · Traditional | 02/24/1986SE |
| K853817 | Cobe Ren New-D Dispensing KitLIF · Traditional | 10/17/1985SE |
| K853100 | Cobe Catheter W/Guidewire Assembly KitDYB · Traditional | 09/25/1985SE |
| K851289 | Cobe Gas FilterKRI · Traditional | 06/19/1985SE |
| K851306 | Cobe System 3FKP · Traditional | 06/12/1985SE |
| K842908 | Variable Prime Cobe Membrane LungDTZ · Traditional | 02/01/1985SE |
| K843709 | Cobe Saturation CellDRY · Traditional | 10/24/1984SE |
| K842138 | Cobe Emergency Power Source 43610-000DTQ · Traditional | 08/03/1984SE |
| K842054 | Cobe AepsKRL · Traditional | 08/02/1984SE |
| K840680 | Centry 2000 Dialysis Control UnitKDI · Traditional | 04/20/1984SE |
| K832671 | Cardiotomy Reservoir-Filter 050-108-050DTN · Traditional | 12/27/1983SE |
| K830629 | Cobe RX MeterFLB · Traditional | 04/06/1983SE |
| K823338 | Cobe Hemoconcentrator 1.3KDI · Traditional | 01/07/1983SE |
| K823092 | Hemaflo Blood Tubing SetsFKQ · Traditional | 11/22/1982SE |
| K820694 | Cobe PPD 1.3L, #18-520-009FJG · Traditional | 03/31/1982SE |
| K820173 | Cobe Single-Needle Controller #18-756FIF · Traditional | 03/23/1982SE |
| K820125 | Cobe Centry 2000 RX · Traditional | 03/23/1982SE |
| K820238 | Cobe Acuflex SSN, #15-220LFJ · Traditional | 03/10/1982SE |
| K820237 | Cobe Acuflex FSN, #15-208LFK · Traditional | 03/10/1982SE |
| K812336 | Cobe PPD 1.9FJG · Traditional | 08/31/1981SE |
| K812093 | Cobe Heat Exchanger Reservoir ModuleDTR · Traditional | 08/13/1981SE |
| K810066 | Cobe PPD .8FJG · Traditional | 06/09/1981SE |
| K810637 | Cobe Disposable Pressure TransducerDRS · Traditional | 04/23/1981SE |
| K810505 | Cardiopulmonary Bypass OxygenatorDTZ · Traditional | 04/23/1981SE |
| K810280 | Dialysate Concentrate for HemodialysisKPO · Traditional | 02/19/1981SE |
| K802895 | Cobe Centry 2 Variable CONCENTRATE-18-KDC · Traditional | 12/22/1980SE |
| K802250 | Dialysis Control Unit-Centry 2000FKP · Traditional | 12/10/1980SE |
| K802714 | Cobe/Stockert Battery ModuleDWB · Traditional | 11/26/1980SE |
| K801178 | Cobe HF80, Cat. #18-580FJI · Traditional | 07/28/1980SE |
| K801211 | Cobe Hemoflo Blood Tubing SetsFJK · Traditional | 07/14/1980SE |
| K800717 | Topical Cooling Dev. Tcd. #27-999DTR · Traditional | 04/16/1980SE |
| K791086 | Centry 2 System #016, 103, 016, 104FIP · Traditional | 07/03/1979SE |
| K790546 | Flowmeter, Optiflo GasDTX · Traditional | 05/11/1979SE |
| K790356 | Oxygenator, Cobe Catalog #42-220DTZ · Traditional | 03/09/1979SE |
| K781764 | Pad, Cooling #27-999DTR · Traditional | 12/04/1978SE |
| K781558 | Pressure Monitoring Injection LinesDQO · Traditional | 10/10/1978SE |
| K781579 | Modified Sterile Disposable StopcocksDTL · Traditional | 10/05/1978SE |
| K780653 | Extracorpeal Cardiotomy Blood FilterJOD · Traditional | 06/14/1978SE |
| K780271 | Cobe StopcockDTL · Traditional | 03/02/1978SE |
| K772284 | Bubble-Type OxygenatorDTZ · Traditional | 02/02/1978SE |
| K771692 | Tubing SetsDWF · Traditional | 10/04/1977SE |
| K770857 | Dialysis Machine, Centry IIFJF · Traditional | 10/04/1977SE |
| K770867 | Dialyzer, Fiber, HollowFJI · Traditional | 06/14/1977SE |
| K770578 | Parallel Plate DialyzerFJG · Traditional | 04/15/1977SE |
| K770383 | Stopcock, One WayKOC · Traditional | 03/07/1977SE |
| K770002 | Console, Mobile for 3 Pumps W/MastsDTQ · Traditional | 03/07/1977SE |
| K760815 | Fitting/DialyzerFTG · Traditional | 11/19/1976SE |
| K760665 | Fistula Needle (#11-265)KOC · Traditional | 10/21/1976SE |
| K760252 | Dialyzer, HF 130 Hollow FiberFJI · Traditional | 10/15/1976SE |
| K760624 | Small Vessel CannulaDWS · Traditional | 09/17/1976SE |