FDA.reportPublic FDA data

510(k) K040355

Device
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING
Applicant
Gish Biomedical, Inc.
510(k) number
K040355
Product code
DTR
Decision
Substantially Equivalent (SESE)
Decision date
2004-03-15
Date received
2004-02-12
Regulation
870.4240
Classification name
Heat-Exchanger, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
J. HARVEY KNAUSS
Address
11874 S. Evelyn Cir. Houston TX US 77071 77071

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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