Gish Biomedical, Inc. - FDA 510(k) Cleared Devices
75
Total
75
Cleared
0
Denied
61 devices
Cleared
Feb 14, 1994
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
Cardiovascular
76d
Cleared
May 17, 1993
ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS
Cardiovascular
339d
Cleared
Apr 06, 1993
GISH ARTERIAL FILTER
Cardiovascular
531d
Cleared
Dec 18, 1991
CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES
Cardiovascular
121d
Cleared
May 22, 1991
CATHCAP, CAT. NO. CC100 SERIES
Cardiovascular
48d
Cleared
Jan 23, 1991
FLEXIBLE INTRACARDIAC SUCTION DEVICE
Cardiovascular
78d
Cleared
Jul 31, 1990
SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM
Cardiovascular
239d
Cleared
May 17, 1990
EXTRACORPOREAL HEAT EXCHANGER HE SERIES
Cardiovascular
213d
Cleared
Jun 13, 1989
ROBICSEK INTRACARDIAC SUCTION WAND
Cardiovascular
78d
Cleared
Mar 10, 1989
CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS
Cardiovascular
37d
Cleared
Dec 05, 1988
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS
Cardiovascular
175d
Cleared
Nov 04, 1988
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
Cardiovascular
49d
Cleared
Sep 26, 1988
VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT
Cardiovascular
73d
Cleared
May 13, 1988
STAT-SAT
Cardiovascular
171d
Cleared
Jan 19, 1988
CAP-35 AND CAP35 F
Cardiovascular
48d
Cleared
Sep 25, 1987
VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER
Cardiovascular
52d
Cleared
Aug 03, 1987
CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS
Cardiovascular
89d
Cleared
Jun 25, 1987
SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX
Cardiovascular
272d
Cleared
Jun 24, 1987
J-CATH, GISH MODEL NO. JVAC-XXXX
Cardiovascular
271d
Cleared
Jun 24, 1987
STAT-VAC CHEST DRAINAGE SYSTEM
Cardiovascular
49d
Cleared
Apr 28, 1987
THORASTAT ATR-XXXX
Cardiovascular
61d
Cleared
Aug 29, 1986
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV
Cardiovascular
58d
Cleared
May 28, 1986
CPS-3000 CARDIOPLEGIA RESERVOIR
Cardiovascular
65d
Cleared
May 28, 1986
CHEST DRAINAGE PACK, CDP-1000
Cardiovascular
65d
Cleared
May 08, 1986
VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER
Cardiovascular
171d