Gish Biomedical, Inc.
Medical device manufacturer in Rancho Santa Margarita, CA.
75510(k) clearances
0PMA approvals
0recalls
Device types
- DTN Reservoir, Blood, Cardiopulmonary Bypass 16
- DTR Heat-Exchanger, Cardiopulmonary Bypass 10
- DQY Catheter, Percutaneous 7
- DTZ Oxygenator, Cardiopulmonary Bypass 6
- DTL Adaptor, Stopcock, Manifold, Fitting… 4
- DTM Filter, Blood, Cardiopulmonary Bypass… 4
- DTP Defoamer, Cardiopulmonary Bypass 3
- DTS Sucker, Cardiotomy Return, Cardiopulmonary… 2
- CAC Apparatus, Autotransfusion 2
- LJT Port & Catheter, Implanted, Subcutaneous… 2
- DWF Catheter, Cannula And Tubing, Vascular… 2
- FMI Needle, Hypodermic, Single Lumen 1
- LFJ Catheter, Subclavian 1
- DXT Injector And Syringe, Angiographic 1
- DWD Suction Control, Intracardiac… 1
- BSO Catheter, Conduction, Anesthetic 1
- CAH Filter, Bacterial, Breathing-Circuit 1
- GBS Catheter, Ventricular, General & Plastic… 1
- KFM Pump, Blood, Cardiopulmonary Bypass… 1
- KRJ Filter, Prebypass, Cardiopulmonary Bypass 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K090450 | Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LTDTZ · Traditional | 09/18/2009SE |
| K090449 | Medos Hilite Infant Oxygenator, Model 1000, 800 LTDTZ · Traditional | 09/18/2009SE |
| K091062 | Medos Hilite Infant Reservoir, Model MVC 0730DTN · Traditional | 08/04/2009SE |
| K083131 | Medos Hilite Reservoir, Model: 4030DTN · Traditional | 07/30/2009SE |
| K082403 | Medos Hilite Oxygenator, Model 7000 & 7000 LTDTZ · Traditional | 05/15/2009SE |
| K082082 | Gish SVR Soft Venous Reservoirs with Ha CoatingDTN · Traditional | 02/04/2009SE |
| K081947 | Gish CAPVRF44 Hardshell Venous Reservoir with Ha CoatingDTN · Traditional | 02/04/2009SE |
| K080708 | Vision Hollow Fiber Oxygenator with Ha CoatingDTZ · Traditional | 02/02/2009SE |
| K081838 | Gish Vision Blood Cardioplegia with Ha CoatingDTR · Traditional | 01/26/2009SE |
| K081881 | Gish Tubing and Connectors with Ha CoatingDWF · Traditional | 01/23/2009SE |
| K081054 | Gish Arterial Filter with Ha CoatingDTM · Traditional | 01/15/2009SE |
| K051606 | Gish ATR2900 and CAP35 Series Reservoirs with GBS CoatingDTN · Traditional | 08/12/2005SE |
| K050195 | V-Bag with GBS CoatingDTN · Traditional | 03/17/2005SE |
| K040355 | Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS CoatingDTR · Traditional | 03/15/2004SE |
| K030726 | Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingDTN · Traditional | 05/30/2003SE |
| K031300 | Ibc Flopump with GBS CoatingKFM · Traditional | 05/14/2003SE |
| K023833 | Gish Arterial Filter with GBS CoatingDTM · Traditional | 03/31/2003SE |
| K023381 | Vision Hollow Fiber Oxygenator with Guardian CoatingDTZ · Traditional | 03/31/2003SE |
| K030077 | Gish Tubing and Connectors with GBS CoatingDTL · Traditional | 03/14/2003SE |
| K024065 | Soft Venous Reservoir (Svrxx) with GBS CoatingDTN · Traditional | 03/05/2003SE |
| K020106 | Vision Blood Cardioplegia System and Extracorporeal Heat ExchangerDTR · Traditional | 04/10/2002SE |
| K964973 | Gish Cap VRF45 Cardiotomy/Venous ReservoirDTN · Traditional | 03/10/1997SE |
| K961530 | Gish Reliance Oxygenator (Model Hfo)DTZ · Traditional | 12/05/1996SE |
| K955046 | Soft Venous ReservoirDTN · Traditional | 01/11/1996SE |
| K954433 | Vasport Dual Lumen Vascular Access SystemLJT · Traditional | 11/15/1995SE |
| K953571 | Vasport Vascular Access PortLJT · Traditional | 10/02/1995SE |
| K944219 | Single Pass Blood Cardioplegia SPBC System ComponentsDTR · Traditional | 06/30/1995SE |
| K936286 | ATR-2900DF (with Depth FILTER)/CAP-35DF (with Depth Filter)DTN · Traditional | 02/14/1994SE |
| K922840 | Antegrade/Retrograde Cardioplegia Valve SystemsDTL · Traditional | 05/17/1993SE |
| K914791 | Gish Arterial FilterDTM · Traditional | 04/06/1993SE |
| K913691 | Cps-Plus Cardioplegia Systems, Cat# Cps-X SeriesDTR · Traditional | 12/18/1991SE |
| K912019 | Orthofuser Wound Drainage/Autotransfusion SystemCAC · Traditional | 10/08/1991SE |
| K911519 | Cathcap, Cat. No. CC100 SeriesDQY · Traditional | 05/22/1991SE |
| K910868 | Temperature Well Probe, TWP SeriesFLL · Traditional | 04/22/1991SE |
| K905008 | Flexible Intracardiac Suction DeviceDTS · Traditional | 01/23/1991SE |
| K896807 | SPBC Series Single Pass Blood Cardioplegia SystemDTR · Traditional | 07/31/1990SE |
| K896020 | Extracorporeal Heat Exchanger He SeriesDTR · Traditional | 05/17/1990SE |
| K892443 | Blood Recovery/Autotransfusion Reservoir ATR-2900CAC · Traditional | 11/08/1989SE |
| K893649 | Meconium AspiratorGCX · Traditional | 08/21/1989SE |
| K891906 | Robicsek Intracardiac Suction WandDTS · Traditional | 06/13/1989SE |
| K890504 | Cardiotomy/Autotransfusion/Pleural Drainage VenousJOD · Traditional | 03/10/1989SE |
| K882414 | Blood Reservoir, Cardiopulmonary BypassDTN · Traditional | 12/05/1988SE |
| K883923 | Cardiotomy/Venous Reservoir No.: CVR SeriesDTN · Traditional | 11/04/1988SE |
| K882969 | Vascular Access Port/Catheter No.Vp-Xxx VasportDQY · Traditional | 09/26/1988SE |
| K874839 | Stat-SatDRY · Traditional | 05/13/1988SE |
| K874924 | CAP-35 and CAP35 FDTP · Traditional | 01/19/1988SE |
| K873377 | Closed Chest Drainage Set W/SuturesGBS · Traditional | 10/28/1987SE |
| K873035 | Vascular Access Port/Cath Cat. #Vp-Xxx Vasport SerDQY · Traditional | 09/25/1987SE |
| K871774 | Ccs-Xxx, Cardioplegia Administration SetsDTR · Traditional | 08/03/1987SE |
| K871873 | Closed Chest Drainage SetLRO · Traditional | 07/09/1987SE |
| K863791 | Subclavian, Gish Model No. Svac-XxxxDQY · Traditional | 06/25/1987SE |
| K871775 | Stat-Vac Chest Drainage SystemDTN · Traditional | 06/24/1987SE |
| K863790 | J-Cath, Gish Model No. Jvac-XxxxDQY · Traditional | 06/24/1987SE |
| K870792 | Thorastat Atr-XxxxDTP · Traditional | 04/28/1987SE |
| K863792 | Duracath, Gish Model No. Dvac-XxxxBSO · Traditional | 12/05/1986SE |
| K862540 | Left Ventricular Vent Valve Model No. GLVDWD · Traditional | 08/29/1986SE |
| K861103 | Chest Drainage Pack, CDP-1000DWF · Traditional | 05/28/1986SE |
| K861102 | CPS-3000 Cardioplegia ReservoirDTR · Traditional | 05/28/1986SE |
| K854610 | Vascular Access Port/Cath Cat.#Vp-Xxxx Vasport SerDQY · Traditional | 05/08/1986SE |
| K860094 | Hurwitz Dialysis CatheterLFJ · Traditional | 04/07/1986SE |
| K853731 | Hemed Needle Support Catalog No. Hap-XxxxFMI · Traditional | 10/18/1985SE |
| K851003 | Arterial Filter Afs-Xx /Filter Holder Afs-HxxDTM · Traditional | 07/29/1985SE |
| K851004 | Cardiotomy Reservoir Brs-Xxx & Holder Brs-HxxDTP · Traditional | 05/16/1985SE |
| K843888 | Cardiotomy Reservoir Brs-Xxx Series &DTN · Traditional | 02/14/1985SE |
| K844229 | Venous Reservoir Vrs-Xxx Series; Holder Vrs-HxxDTN · Traditional | 01/14/1985SE |
| K833644 | Filter Purge Line Ec-Fpl SeriesDTL · Traditional | 12/29/1984SE |
| K841587 | Central Venous Access Catheter Cvac-XxDQY · Traditional | 06/13/1984SE |
| K841535 | Triple Lumen Infusion Catheter/Access · Traditional | 05/23/1984SE |
| K833645 | Contrast Media Inject. Set CMSDXT · Traditional | 04/17/1984SE |
| K833662 | Cardioplegia System Ccs-Xxx SeriesDTR · Traditional | 12/29/1983SE |
| K833322 | Tubing Connectors EC-2XXX SeriesDTL · Traditional | 12/16/1983SE |
| K832935 | Gasline Filter, #Ec-Glf SeriesCAH · Traditional | 11/22/1983SE |
| K833030 | Intravascular Administration SetFPA · Traditional | 11/03/1983SE |
| K832594 | Pre-Bypass Filter #Ec-Pbf SeriesKRJ · Traditional | 09/20/1983SE |
| K832396 | Central Venous Access Catheter CvacDOY · Traditional | 08/31/1983SE |