FDA.reportPublic FDA data

510(k) K033641

Device
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
Applicant
Cobe Cardiovascular, Inc.
510(k) number
K033641
Product code
DTN
Decision
Substantially Equivalent (SESE)
Decision date
2003-12-11
Date received
2003-11-20
Regulation
870.4400
Classification name
Reservoir, Blood, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
LYNNE LEONARD
Address
14401 W. 65th Way Arvada CO US 80004 80004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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