FDA 510(k) Applications Submitted by GISH BIOMEDICAL, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K955046 |
11/03/1995 |
SOFT VENOUS RESERVOIR |
GISH BIOMEDICAL, INC. |
| K081881 |
07/02/2008 |
GISH TUBING AND CONNECTORS WITH HA COATING |
GISH BIOMEDICAL, INC. |
| K080708 |
03/12/2008 |
VISION HOLLOW FIBER OXYGENATOR WITH HA COATING |
GISH BIOMEDICAL, INC. |
| K081054 |
04/14/2008 |
GISH ARTERIAL FILTER WITH HA COATING |
GISH BIOMEDICAL, INC. |
| K081947 |
07/08/2008 |
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING |
GISH BIOMEDICAL, INC. |
| K082403 |
08/21/2008 |
MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT |
GISH BIOMEDICAL, INC. |
| K024065 |
12/09/2002 |
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K030077 |
01/08/2003 |
GISH TUBING AND CONNECTORS WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K050195 |
01/27/2005 |
V-BAG WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K040355 |
02/12/2004 |
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K030726 |
03/07/2003 |
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K031300 |
04/24/2003 |
IBC FLOPUMP WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K051606 |
06/16/2005 |
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K023381 |
10/08/2002 |
VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING |
GISH BIOMEDICAL, INC. |
| K023833 |
11/18/2002 |
GISH ARTERIAL FILTER WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K961530 |
04/22/1996 |
GISH RELIANCE OXYGENATOR (MODEL HFO) |
GISH BIOMEDICAL, INC. |
| K020106 |
01/11/2002 |
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER |
GISH BIOMEDICAL, INC. |
| K090449 |
02/20/2009 |
MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT |
GISH BIOMEDICAL, INC. |
| K090450 |
02/20/2009 |
MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT |
GISH BIOMEDICAL, INC. |
| K091062 |
04/14/2009 |
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 |
GISH BIOMEDICAL, INC. |
| K083131 |
10/23/2008 |
MEDOS HILITE RESERVOIR, MODEL: 4030 |
GISH BIOMEDICAL, INC. |
| K964973 |
12/12/1996 |
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR |
GISH BIOMEDICAL, INC. |
| K081838 |
06/30/2008 |
GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING |
GISH BIOMEDICAL, INC. |
| K082082 |
07/23/2008 |
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING |
GISH BIOMEDICAL, INC. |
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