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510(k) K891906

Device
ROBICSEK INTRACARDIAC SUCTION WAND
Applicant
GISH BIOMEDICAL, INC.
510(k) number
K891906
Product code
DTS  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-13
Date received
1989-03-27
Regulation
870.4420
Classification name
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LORI GLASTETTER
Address
2350 S. Pullman Ave. Santa Ana CA US 92705 92705

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DTS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K053021ESTECH CLEARVIEW MV ATRIAL DEPRESSOREstech, Inc.2006-01-26
K982891CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDSCalifornia Medical Laboratories, Inc.1998-09-30
K963756IBC CARDIAC SUCTION WARDInternational Biophysics Corp.1997-11-14
K905008FLEXIBLE INTRACARDIAC SUCTION DEVICEGish Biomedical, Inc.1991-01-23
K900339HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLESShiley, Inc.1990-03-28
K801641OHIO DISPOSABLE CLEAR SUCTION INSTRUMENTOhio Medical Products1980-07-28
K801400DISPOSABLE SUCKER SYSTEMTexas Medical Products, Inc.1980-06-30
K791846DISPOSSABLE SUCTION TUBE, 6 FRENCHDlp, Inc.1979-10-02

Legacy Summary#

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FDA Review#

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