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

Cleared Oct 02, 1995

VASPORT VASCULAR ACCESS PORT

K953571 · LJT

General Hospital · 63d

Cleared Jun 30, 1995

SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS

K944219 · DTR

Cardiovascular · 305d

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 Oct 08, 1991

ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM

K912019 · CAC

Anesthesiology · 154d

Cleared May 22, 1991

CATHCAP, CAT. NO. CC100 SERIES

K911519 · DQY

Cardiovascular · 48d

Cleared Apr 22, 1991

TEMPERATURE WELL PROBE, TWP SERIES

K910868 · FLL

General Hospital · 52d

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 Nov 08, 1989

BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900

K892443 · CAC

Anesthesiology · 212d

Cleared Aug 21, 1989

MECONIUM ASPIRATOR

K893649 · GCX

General Hospital · 98d

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 Oct 28, 1987

CLOSED CHEST DRAINAGE SET W/SUTURES

K873377 · GBS

General & Plastic Surgery · 65d

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 Jul 09, 1987

CLOSED CHEST DRAINAGE SET

K871873 · LRO

General & Plastic Surgery · 57d