Cobe Laboratories, Inc.
Mchenry, IL, US
Cobe Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 77 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 77
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 77FDA records hold 77 510(k) clearances for Cobe Laboratories, Inc. between 1976 and 1993. The busiest year on record is 1990, with 9. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 6 |
| 1978 | 6 |
| 1979 | 3 |
| 1980 | 6 |
| 1981 | 6 |
| 1982 | 6 |
| 1983 | 3 |
| 1984 | 4 |
| 1985 | 5 |
| 1986 | 7 |
| 1987 | 2 |
| 1988 | 4 |
| 1989 | 2 |
| 1990 | 9 |
| 1991 | 3 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K923272 | COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K900105 | COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC | LKN | Substantially Equivalent | |
| K905793 | COBE CENTRY 2 BICART OPTION KIT | FKP | Substantially Equivalent | |
| K905388 | COBE CENTRYSYSTEM 3 BICART OPTION KIT | FKP | Substantially Equivalent | |
| K904336 | NEW COBE SATURATION/HEMATOCRIT MONITOR | GKF | Substantially Equivalent | |
| K902631 | COBE ICU CONVERSION KIT | DTN | Substantially Equivalent | |
| K902437 | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | DTP | Substantially Equivalent | |
| K904566 | NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER | FJI | Substantially Equivalent | |
| K902758 | COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC | DQA | Substantially Equivalent | |
| K902759 | COBE CLOSED WOUND DRAINAGE KIT | CAC | Substantially Equivalent | |
| K902671 | COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER | CAC | Substantially Equivalent | |
| K900910 | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) | DTW | Substantially Equivalent | |
| K900758 | HEPARINIZED ARTERIAL SCREEN BLOOD FILTER | DTM | Substantially Equivalent | |
| K895076 | CMS VRB-1200 | DTN | Substantially Equivalent | |
| K893962 | COBE 2991 SUPPLEMENTARY DISPOSABLE SETS | LKN | Substantially Equivalent | |
| K881811 | COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS | FJI | Substantially Equivalent | |
| K881330 | COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK | DWF | Substantially Equivalent | |
| K881062 | CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 | FJB | Substantially Equivalent | |
| K880021 | COBE CML3 | DTZ | Substantially Equivalent | |
| K870976 | ONGUARD 1000, CATALOG #043611-000 & 043611-001 | DTQ | Substantially Equivalent | |
| K864831 | COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS | FJI | Substantially Equivalent | |
| K861808 | VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN | DSY | Substantially Equivalent | |
| K861860 | COBE ACCESSORY INTERFACE MODULE (AIM) | KRL | Substantially Equivalent | |
| K855064 | SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE | CAK | Substantially Equivalent | |
| K855065 | PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE | FPB | Substantially Equivalent | |
| K855067 | SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 | JOD | Substantially Equivalent | |
| K855066 | SWANK ARTERIAL LINE BLOOD FILTER HF6000 | DTM | Substantially Equivalent | |
| K853101 | VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES | DSY | Substantially Equivalent | |
| K853817 | COBE REN NEW-D DISPENSING KIT | LIF | Substantially Equivalent | |
| K853100 | COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT | DYB | Substantially Equivalent | |
| K851289 | COBE GAS FILTER | KRI | Substantially Equivalent | |
| K851306 | COBE SYSTEM 3 | FKP | Substantially Equivalent | |
| K842908 | VARIABLE PRIME COBE MEMBRANE LUNG | DTZ | Substantially Equivalent | |
| K843709 | COBE SATURATION CELL | DRY | Substantially Equivalent | |
| K842138 | COBE EMERGENCY POWER SOURCE 43610-000 | DTQ | Substantially Equivalent | |
| K842054 | COBE AEPS | KRL | Substantially Equivalent | |
| K840680 | CENTRY 2000 DIALYSIS CONTROL UNIT | KDI | Substantially Equivalent | |
| K832671 | CARDIOTOMY RESERVOIR-FILTER 050-108-050 | DTN | Substantially Equivalent | |
| K830629 | COBE RX METER | FLB | Substantially Equivalent | |
| K823338 | COBE HEMOCONCENTRATOR 1.3 | KDI | Substantially Equivalent | |
| K823092 | HEMAFLO BLOOD TUBING SETS | FKQ | Substantially Equivalent | |
| K820694 | COBE PPD 1.3L, #18-520-009 | FJG | Substantially Equivalent | |
| K820173 | COBE SINGLE-NEEDLE CONTROLLER #18-756 | FIF | Substantially Equivalent | |
| K820125 | COBE CENTRY 2000 RX | Substantially Equivalent | ||
| K820238 | COBE ACUFLEX SSN, #15-220 | LFJ | Substantially Equivalent | |
| K820237 | COBE ACUFLEX FSN, #15-208 | LFK | Substantially Equivalent | |
| K812336 | COBE PPD 1.9 | FJG | Substantially Equivalent | |
| K812093 | COBE HEAT EXCHANGER RESERVOIR MODULE | DTR | Substantially Equivalent | |
| K810066 | COBE PPD .8 | FJG | Substantially Equivalent | |
| K810637 | COBE DISPOSABLE PRESSURE TRANSDUCER | DRS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- CACApparatus, Autotransfusion
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- LFKCatheter, Femoral
- DQOCatheter, Intravascular, Diagnostic
- LFJCatheter, Subclavian
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
- DTPDefoamer, Cardiopulmonary Bypass
- FJFDetector, Air Bubble
- KRLDetector, Bubble, Cardiopulmonary Bypass
- FJBDetector, Dialysate Level
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- LIFDialyzer Reprocessing System
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- FJGDialyzer, Parallel Flow
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- FPBFilter, Infusion Line
- DTXGas Control Unit, Cardiopulmonary Bypass
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- FTGIlluminator, Remote
- GKFInstrument, Hematocrit, Automated
- KDCInstrument, Surgical, Disposable
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- FLBMeter, Conductivity, Induction, Remote Type
- CAKMicrofilter, Blood Transfusion
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- DQAOximeter
- DTZOxygenator, Cardiopulmonary Bypass
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type
- DTNReservoir, Blood, Cardiopulmonary Bypass
- LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic
- FIFSet, Dialysis, Single Needle With Uni-Directional Pump
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FIPSubsystem, Water Purification
- FKQSystem, Dialysate Delivery, Central Multiple Patient
- FKPSystem, Dialysate Delivery, Single Patient
- DRSTransducer, Blood-Pressure, Extravascular
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain