Company ยท US
Gish Biomedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2009. Name variants (Inc, Corp, punctuation) are merged.
75510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 16 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 10 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 9 |
| DQY | Catheter, Percutaneous | 7 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 4 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 4 |
| DTP | Defoamer, Cardiopulmonary Bypass | 3 |
| CAC | Apparatus, Autotransfusion | 2 |
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| DOY | Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 |
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | 1 |
| DXT | Injector And Syringe, Angiographic | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| FPA | Set, Administration, Intravascular | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2009 | K090450 | MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT Gish Biomedical, Inc. | DTZ |
| Sep 18, 2009 | K090449 | MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT Gish Biomedical, Inc. | DTZ |
| Aug 4, 2009 | K091062 | MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 Gish Biomedical, Inc. | DTN |
| Jul 30, 2009 | K083131 | MEDOS HILITE RESERVOIR, MODEL: 4030 Gish Biomedical, Inc. | DTN |
| May 15, 2009 | K082403 | MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT Gish Biomedical, Inc. | DTZ |
| Feb 4, 2009 | K082082 | GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING Gish Biomedical, Inc. | DTN |
| Feb 4, 2009 | K081947 | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING Gish Biomedical, Inc. | DTN |
| Feb 2, 2009 | K080708 | VISION HOLLOW FIBER OXYGENATOR WITH HA COATING Gish Biomedical, Inc. | DTZ |
| Jan 26, 2009 | K081838 | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING Gish Biomedical, Inc. | DTR |
| Jan 23, 2009 | K081881 | GISH TUBING AND CONNECTORS WITH HA COATING Gish Biomedical, Inc. | DWF |
| Jan 15, 2009 | K081054 | GISH ARTERIAL FILTER WITH HA COATING Gish Biomedical, Inc. | DTM |
| Aug 12, 2005 | K051606 | GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING Gish Biomedical, Inc. | DTN |
| Mar 17, 2005 | K050195 | V-BAG WITH GBS COATING Gish Biomedical, Inc. | DTN |
| Mar 15, 2004 | K040355 | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING Gish Biomedical, Inc. | DTR |
| May 30, 2003 | K030726 | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING Gish Biomedical, Inc. | DTN |
| May 14, 2003 | K031300 | IBC FLOPUMP WITH GBS COATING Gish Biomedical, Inc. | KFM |
| Mar 31, 2003 | K023833 | GISH ARTERIAL FILTER WITH GBS COATING Gish Biomedical, Inc. | DTM |
| Mar 31, 2003 | K023381 | VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING Gish Biomedical, Inc. | DTZ |
| Mar 14, 2003 | K030077 | GISH TUBING AND CONNECTORS WITH GBS COATING Gish Biomedical, Inc. | DTL |
| Mar 5, 2003 | K024065 | SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING Gish Biomedical, Inc. | DTN |
| Apr 10, 2002 | K020106 | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER Gish Biomedical, Inc. | DTR |
| Mar 10, 1997 | K964973 | GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR Gish Biomedical, Inc. | DTN |
| Dec 5, 1996 | K961530 | GISH RELIANCE OXYGENATOR (MODEL HFO) Gish Biomedical, Inc. | DTZ |
| Jan 11, 1996 | K955046 | SOFT VENOUS RESERVOIR Gish Biomedical, Inc. | DTN |
| Nov 15, 1995 | K954433 | VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM Gish Biomedical, Inc. | LJT |
| Oct 2, 1995 | K953571 | VASPORT VASCULAR ACCESS PORT Gish Biomedical, Inc. | LJT |
| Jun 30, 1995 | K944219 | SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS Gish Biomedical, Inc. | DTR |
| Feb 14, 1994 | K936286 | ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) Gish Biomedical, Inc. | DTN |
| May 17, 1993 | K922840 | ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS Gish Biomedical, Inc. | DTL |
| Apr 6, 1993 | K914791 | GISH ARTERIAL FILTER Gish Biomedical, Inc. | DTM |
| Dec 18, 1991 | K913691 | CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES Gish Biomedical, Inc. | DTR |
| Oct 8, 1991 | K912019 | ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM Gish Biomedical, Inc. | CAC |
| May 22, 1991 | K911519 | CATHCAP, CAT. NO. CC100 SERIES Gish Biomedical, Inc. | DQY |
| Apr 22, 1991 | K910868 | TEMPERATURE WELL PROBE, TWP SERIES Gish Biomedical, Inc. | FLL |
| Jan 23, 1991 | K905008 | FLEXIBLE INTRACARDIAC SUCTION DEVICE Gish Biomedical, Inc. | DTS |
| Jul 31, 1990 | K896807 | SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM Gish Biomedical, Inc. | DTR |
| May 17, 1990 | K896020 | EXTRACORPOREAL HEAT EXCHANGER HE SERIES Gish Biomedical, Inc. | DTR |
| Nov 8, 1989 | K892443 | BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900 Gish Biomedical, Inc. | CAC |
| Aug 21, 1989 | K893649 | MECONIUM ASPIRATOR Gish Biomedical, Inc. | GCX |
| Jun 13, 1989 | K891906 | ROBICSEK INTRACARDIAC SUCTION WAND Gish Biomedical, Inc. | DTS |
| Mar 10, 1989 | K890504 | CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS Gish Biomedical, Inc. | JOD |
| Dec 5, 1988 | K882414 | BLOOD RESERVOIR, CARDIOPULMONARY BYPASS Gish Biomedical, Inc. | DTN |
| Nov 4, 1988 | K883923 | CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES Gish Biomedical, Inc. | DTN |
| Sep 26, 1988 | K882969 | VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT Gish Biomedical, Inc. | DQY |
| May 13, 1988 | K874839 | STAT-SAT Gish Biomedical, Inc. | DRY |
| Jan 19, 1988 | K874924 | CAP-35 AND CAP35 F Gish Biomedical, Inc. | DTP |
| Oct 28, 1987 | K873377 | CLOSED CHEST DRAINAGE SET W/SUTURES Gish Biomedical, Inc. | GBS |
| Sep 25, 1987 | K873035 | VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER Gish Biomedical, Inc. | DQY |
| Aug 3, 1987 | K871774 | CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS Gish Biomedical, Inc. | DTR |
| Jul 9, 1987 | K871873 | CLOSED CHEST DRAINAGE SET Gish Biomedical, Inc. | LRO |
Newest 50 of 75.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2006 | Gish Biomedical Inc The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The Terminated |
DTZ | K040355 |
| Feb 14, 2006 | Gish Biomedical Inc The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal device designed to be used in an extracorp Terminated |
DTZ | K023381 |
| Jul 20, 2004 | Gish Biomedical Inc Vision Hollow Fiber Oxygenator with GBS Coating Terminated |
DTZ | K023381 |
| Apr 22, 2003 | Gish Biomedical Inc Vision Hollow Fiber Oxygenator Terminated |
K961530 |