Company ยท US
Cobe Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1993. Name variants (Inc, Corp, punctuation) are merged.
77510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 6 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 6 |
| FJG | Dialyzer, Parallel Flow | 4 |
| FKP | System, Dialysate Delivery, Single Patient | 4 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 3 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 3 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 3 |
| CAC | Apparatus, Autotransfusion | 2 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 2 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 |
| JOD | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | 2 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 2 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 2 |
| KRL | Detector, Bubble, Cardiopulmonary Bypass | 2 |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 2 |
| CAK | Microfilter, Blood Transfusion | 1 |
| DQA | Oximeter | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 11, 1993 | K923272 | COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Laboratories, Inc. | DTZ |
| Mar 22, 1991 | K900105 | COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC Cobe Laboratories, Inc. | LKN |
| Feb 12, 1991 | K905793 | COBE CENTRY 2 BICART OPTION KIT Cobe Laboratories, Inc. | FKP |
| Feb 11, 1991 | K905388 | COBE CENTRYSYSTEM 3 BICART OPTION KIT Cobe Laboratories, Inc. | FKP |
| Dec 27, 1990 | K904336 | NEW COBE SATURATION/HEMATOCRIT MONITOR Cobe Laboratories, Inc. | GKF |
| Dec 17, 1990 | K902631 | COBE ICU CONVERSION KIT Cobe Laboratories, Inc. | DTN |
| Dec 17, 1990 | K902437 | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER Cobe Laboratories, Inc. | DTP |
| Dec 12, 1990 | K904566 | NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER Cobe Laboratories, Inc. | FJI |
| Aug 23, 1990 | K902758 | COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC Cobe Laboratories, Inc. | DQA |
| Jul 18, 1990 | K902759 | COBE CLOSED WOUND DRAINAGE KIT Cobe Laboratories, Inc. | CAC |
| Jul 17, 1990 | K902671 | COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER Cobe Laboratories, Inc. | CAC |
| May 22, 1990 | K900910 | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) Cobe Laboratories, Inc. | DTW |
| May 17, 1990 | K900758 | HEPARINIZED ARTERIAL SCREEN BLOOD FILTER Cobe Laboratories, Inc. | DTM |
| Nov 3, 1989 | K895076 | CMS VRB-1200 Cobe Laboratories, Inc. | DTN |
| Oct 18, 1989 | K893962 | COBE 2991 SUPPLEMENTARY DISPOSABLE SETS Cobe Laboratories, Inc. | LKN |
| Sep 15, 1988 | K881811 | COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS Cobe Laboratories, Inc. | FJI |
| Jun 10, 1988 | K881330 | COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK Cobe Laboratories, Inc. | DWF |
| Apr 21, 1988 | K881062 | CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 Cobe Laboratories, Inc. | FJB |
| Apr 1, 1988 | K880021 | COBE CML3 Cobe Laboratories, Inc. | DTZ |
| May 6, 1987 | K870976 | ONGUARD 1000, CATALOG #043611-000 & 043611-001 Cobe Laboratories, Inc. | DTQ |
| Mar 27, 1987 | K864831 | COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS Cobe Laboratories, Inc. | FJI |
| Sep 15, 1986 | K861808 | VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN Cobe Laboratories, Inc. | DSY |
| Jul 18, 1986 | K861860 | COBE ACCESSORY INTERFACE MODULE (AIM) Cobe Laboratories, Inc. | KRL |
| Mar 12, 1986 | K855064 | SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE Cobe Laboratories, Inc. | CAK |
| Feb 28, 1986 | K855065 | PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE Cobe Laboratories, Inc. | FPB |
| Feb 26, 1986 | K855067 | SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 Cobe Laboratories, Inc. | JOD |
| Feb 26, 1986 | K855066 | SWANK ARTERIAL LINE BLOOD FILTER HF6000 Cobe Laboratories, Inc. | DTM |
| Feb 24, 1986 | K853101 | VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES Cobe Laboratories, Inc. | DSY |
| Oct 17, 1985 | K853817 | COBE REN NEW-D DISPENSING KIT Cobe Laboratories, Inc. | LIF |
| Sep 25, 1985 | K853100 | COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT Cobe Laboratories, Inc. | DYB |
| Jun 19, 1985 | K851289 | COBE GAS FILTER Cobe Laboratories, Inc. | KRI |
| Jun 12, 1985 | K851306 | COBE SYSTEM 3 Cobe Laboratories, Inc. | FKP |
| Feb 1, 1985 | K842908 | VARIABLE PRIME COBE MEMBRANE LUNG Cobe Laboratories, Inc. | DTZ |
| Oct 24, 1984 | K843709 | COBE SATURATION CELL Cobe Laboratories, Inc. | DRY |
| Aug 3, 1984 | K842138 | COBE EMERGENCY POWER SOURCE 43610-000 Cobe Laboratories, Inc. | DTQ |
| Aug 2, 1984 | K842054 | COBE AEPS Cobe Laboratories, Inc. | KRL |
| Apr 20, 1984 | K840680 | CENTRY 2000 DIALYSIS CONTROL UNIT Cobe Laboratories, Inc. | KDI |
| Dec 27, 1983 | K832671 | CARDIOTOMY RESERVOIR-FILTER 050-108-050 Cobe Laboratories, Inc. | DTN |
| Apr 6, 1983 | K830629 | COBE RX METER Cobe Laboratories, Inc. | FLB |
| Jan 7, 1983 | K823338 | COBE HEMOCONCENTRATOR 1.3 Cobe Laboratories, Inc. | KDI |
| Nov 22, 1982 | K823092 | HEMAFLO BLOOD TUBING SETS Cobe Laboratories, Inc. | FKQ |
| Mar 31, 1982 | K820694 | COBE PPD 1.3L, #18-520-009 Cobe Laboratories, Inc. | FJG |
| Mar 23, 1982 | K820173 | COBE SINGLE-NEEDLE CONTROLLER #18-756 Cobe Laboratories, Inc. | FIF |
| Mar 23, 1982 | K820125 | COBE CENTRY 2000 RX Cobe Laboratories, Inc. | |
| Mar 10, 1982 | K820238 | COBE ACUFLEX SSN, #15-220 Cobe Laboratories, Inc. | LFJ |
| Mar 10, 1982 | K820237 | COBE ACUFLEX FSN, #15-208 Cobe Laboratories, Inc. | LFK |
| Aug 31, 1981 | K812336 | COBE PPD 1.9 Cobe Laboratories, Inc. | FJG |
| Aug 13, 1981 | K812093 | COBE HEAT EXCHANGER RESERVOIR MODULE Cobe Laboratories, Inc. | DTR |
| Jun 9, 1981 | K810066 | COBE PPD .8 Cobe Laboratories, Inc. | FJG |
| Apr 23, 1981 | K810637 | COBE DISPOSABLE PRESSURE TRANSDUCER Cobe Laboratories, Inc. | DRS |
Newest 50 of 77.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||