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510(k) K053021

Device
ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
Applicant
ESTECH, INC.
510(k) number
K053021
Product code
DTS  
Decision
Substantially Equivalent (SESE)
Decision date
2006-01-26
Date received
2005-10-26
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
CRAIG COOMBS
Address
1193 Sherman St. Alameda CA US 94501 94501

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
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
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#

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