FDA.reportPublic FDA data

510(k) K963756

Device
IBC CARDIAC SUCTION WARD
Applicant
INTERNATIONAL BIOPHYSICS CORP.
510(k) number
K963756
Product code
DTS  
Decision
Substantially Equivalent (SESE)
Decision date
1997-11-14
Date received
1996-09-17
Regulation
870.4420
Classification name
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
H. DAVID SHOCKLEY, JR.
Address
4020 S. Industrial Dr. Suite 160 Austin TX US 78744 78744

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K905008FLEXIBLE INTRACARDIAC SUCTION DEVICEGish Biomedical, Inc.1991-01-23
K900339HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLESShiley, Inc.1990-03-28
K891906ROBICSEK INTRACARDIAC SUCTION WANDGish Biomedical, Inc.1989-06-13
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#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases