Gish Biomedical, Inc.
Houston, TX, US
Gish Biomedical, Inc. appears in FDA device records in Houston, TX. FDA records list 75 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
Showing 50 of 75FDA records hold 75 510(k) clearances for Gish Biomedical, Inc. between 1983 and 2009. The busiest year on record is 2009, with 11. The most recent is 2009, with 11.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 6 |
| 1984 | 4 |
| 1985 | 5 |
| 1986 | 6 |
| 1987 | 8 |
| 1988 | 5 |
| 1989 | 4 |
| 1990 | 2 |
| 1991 | 5 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 2 |
| 1997 | 1 |
| 2002 | 1 |
| 2003 | 6 |
| 2004 | 1 |
| 2005 | 2 |
| 2009 | 11 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090450 | MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT | DTZ | Substantially Equivalent | |
| K090449 | MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT | DTZ | Substantially Equivalent | |
| K091062 | MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 | DTN | Substantially Equivalent | |
| K083131 | MEDOS HILITE RESERVOIR, MODEL: 4030 | DTN | Substantially Equivalent | |
| K082403 | MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT | DTZ | Substantially Equivalent | |
| K082082 | GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING | DTN | Substantially Equivalent | |
| K081947 | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING | DTN | Substantially Equivalent | |
| K080708 | VISION HOLLOW FIBER OXYGENATOR WITH HA COATING | DTZ | Substantially Equivalent | |
| K081838 | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | DTR | Substantially Equivalent | |
| K081881 | GISH TUBING AND CONNECTORS WITH HA COATING | DWF | Substantially Equivalent | |
| K081054 | GISH ARTERIAL FILTER WITH HA COATING | DTM | Substantially Equivalent | |
| K051606 | GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING | DTN | Substantially Equivalent | |
| K050195 | V-BAG WITH GBS COATING | DTN | Substantially Equivalent | |
| K040355 | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING | DTR | Substantially Equivalent | |
| K030726 | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING | DTN | Substantially Equivalent | |
| K031300 | IBC FLOPUMP WITH GBS COATING | KFM | Substantially Equivalent | |
| K023833 | GISH ARTERIAL FILTER WITH GBS COATING | DTM | Substantially Equivalent | |
| K023381 | VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING | DTZ | Substantially Equivalent | |
| K030077 | GISH TUBING AND CONNECTORS WITH GBS COATING | DTL | Substantially Equivalent | |
| K024065 | SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING | DTN | Substantially Equivalent | |
| K020106 | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER | DTR | Substantially Equivalent | |
| K964973 | GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR | DTN | Substantially Equivalent | |
| K961530 | GISH RELIANCE OXYGENATOR (MODEL HFO) | DTZ | Substantially Equivalent | |
| K955046 | SOFT VENOUS RESERVOIR | DTN | Substantially Equivalent | |
| K954433 | VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM | LJT | Substantially Equivalent | |
| K953571 | VASPORT VASCULAR ACCESS PORT | LJT | Substantially Equivalent | |
| K944219 | SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS | DTR | Substantially Equivalent | |
| K936286 | ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) | DTN | Substantially Equivalent | |
| K922840 | ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS | DTL | Substantially Equivalent | |
| K914791 | GISH ARTERIAL FILTER | DTM | Substantially Equivalent | |
| K913691 | CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES | DTR | Substantially Equivalent | |
| K912019 | ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | |
| K911519 | CATHCAP, CAT. NO. CC100 SERIES | DQY | Substantially Equivalent | |
| K910868 | TEMPERATURE WELL PROBE, TWP SERIES | FLL | Substantially Equivalent | |
| K905008 | FLEXIBLE INTRACARDIAC SUCTION DEVICE | DTS | Substantially Equivalent | |
| K896807 | SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM | DTR | Substantially Equivalent | |
| K896020 | EXTRACORPOREAL HEAT EXCHANGER HE SERIES | DTR | Substantially Equivalent | |
| K892443 | BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900 | CAC | Substantially Equivalent | |
| K893649 | MECONIUM ASPIRATOR | GCX | Substantially Equivalent | |
| K891906 | ROBICSEK INTRACARDIAC SUCTION WAND | DTS | Substantially Equivalent | |
| K890504 | CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS | JOD | Substantially Equivalent | |
| K882414 | BLOOD RESERVOIR, CARDIOPULMONARY BYPASS | DTN | Substantially Equivalent | |
| K883923 | CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES | DTN | Substantially Equivalent | |
| K882969 | VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT | DQY | Substantially Equivalent | |
| K874839 | STAT-SAT | DRY | Substantially Equivalent | |
| K874924 | CAP-35 AND CAP35 F | DTP | Substantially Equivalent | |
| K873377 | CLOSED CHEST DRAINAGE SET W/SUTURES | GBS | Substantially Equivalent | |
| K873035 | VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER | DQY | Substantially Equivalent | |
| K871774 | CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS | DTR | Substantially Equivalent | |
| K871873 | CLOSED CHEST DRAINAGE SET | LRO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- CACApparatus, Autotransfusion
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- BSOCatheter, Conduction, Anesthetic
- DQYCatheter, Percutaneous
- LFJCatheter, Subclavian
- GBSCatheter, Ventricular, General & Plastic Surgery
- FLLContinuous Measurement Thermometer
- DTPDefoamer, Cardiopulmonary Bypass
- CAHFilter, Bacterial, Breathing-Circuit
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- KRJFilter, Prebypass, Cardiopulmonary Bypass
- LROGeneral Surgery Tray
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DXTInjector And Syringe, Angiographic
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- FMINeedle, Hypodermic, Single Lumen
- DTZOxygenator, Cardiopulmonary Bypass
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DOYRadioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
- DTNReservoir, Blood, Cardiopulmonary Bypass
- FPASet, Administration, Intravascular
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0575-06 | 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 heat exchanger consists of a one piece, stainless steel bellows-configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the convolutions, and therefore improves heat exchange, minimizes priming volume, and reduces shunting. All materials of the heat exchanger are biocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air. Additionally, the device includes an integral bubble trap, gross filter and pressure relief device designed to open in the event of excessive fluid pressure during use. Solutions are delivered to the patient through a roller pump through the table line extension and appropriate cannula. | The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks. | Terminated | ||
| Z-0519-06 | 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 extracorporeal blood circuit to control exchange of gases. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood. | Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported. | Terminated | ||
| Z-0730-04 | Vision Hollow Fiber Oxygenator with GBS Coating | Customers reported leakage. | Terminated | ||
| Z-0780-03 | Vision Hollow Fiber Oxygenator | Two reports of leakage. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain