Medical Device Manufacturer · US , Mchenry , IL

Gish Biomedical, Inc. - FDA 510(k) Cleared Devices

75 submissions · 75 cleared · Since 1983
75
Total
75
Cleared
0
Denied
61 devices
26-50 of 61
Cleared Feb 14, 1994
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
K936286 · DTN
Cardiovascular · 76d
Cleared May 17, 1993
ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS
K922840 · DTL
Cardiovascular · 339d
Cleared Apr 06, 1993
GISH ARTERIAL FILTER
K914791 · DTM
Cardiovascular · 531d
Cleared Dec 18, 1991
CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES
K913691 · DTR
Cardiovascular · 121d
Cleared May 22, 1991
CATHCAP, CAT. NO. CC100 SERIES
K911519 · DQY
Cardiovascular · 48d
Cleared Jan 23, 1991
FLEXIBLE INTRACARDIAC SUCTION DEVICE
K905008 · DTS
Cardiovascular · 78d
Cleared Jul 31, 1990
SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM
K896807 · DTR
Cardiovascular · 239d
Cleared May 17, 1990
EXTRACORPOREAL HEAT EXCHANGER HE SERIES
K896020 · DTR
Cardiovascular · 213d
Cleared Jun 13, 1989
ROBICSEK INTRACARDIAC SUCTION WAND
K891906 · DTS
Cardiovascular · 78d
Cleared Mar 10, 1989
CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS
K890504 · JOD
Cardiovascular · 37d
Cleared Dec 05, 1988
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS
K882414 · DTN
Cardiovascular · 175d
Cleared Nov 04, 1988
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
K883923 · DTN
Cardiovascular · 49d
Cleared Sep 26, 1988
VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT
K882969 · DQY
Cardiovascular · 73d
Cleared May 13, 1988
STAT-SAT
K874839 · DRY
Cardiovascular · 171d
Cleared Jan 19, 1988
CAP-35 AND CAP35 F
K874924 · DTP
Cardiovascular · 48d
Cleared Sep 25, 1987
VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER
K873035 · DQY
Cardiovascular · 52d
Cleared Aug 03, 1987
CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS
K871774 · DTR
Cardiovascular · 89d
Cleared Jun 25, 1987
SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX
K863791 · DQY
Cardiovascular · 272d
Cleared Jun 24, 1987
J-CATH, GISH MODEL NO. JVAC-XXXX
K863790 · DQY
Cardiovascular · 271d
Cleared Jun 24, 1987
STAT-VAC CHEST DRAINAGE SYSTEM
K871775 · DTN
Cardiovascular · 49d
Cleared Apr 28, 1987
THORASTAT ATR-XXXX
K870792 · DTP
Cardiovascular · 61d
Cleared Aug 29, 1986
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV
K862540 · DWD
Cardiovascular · 58d
Cleared May 28, 1986
CPS-3000 CARDIOPLEGIA RESERVOIR
K861102 · DTR
Cardiovascular · 65d
Cleared May 28, 1986
CHEST DRAINAGE PACK, CDP-1000
K861103 · DWF
Cardiovascular · 65d
Cleared May 08, 1986
VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER
K854610 · DQY
Cardiovascular · 171d
Filters