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FDA 510(k) Applications Submitted by Jeff Koll
FDA 510(k) Number
Submission Date
Device Name
Applicant
K203004
10/01/2020
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
ACIST Medical Systems, Inc.
K102953
10/04/2010
HEPARIN DOSE RESPONSE CARTRIDGE
MEDTRONIC INC.
K093650
11/25/2009
BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
MEDTRONIC INC.
K080166
01/23/2008
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
BECKMAN COULTER, INC.
K100646
03/05/2010
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
MEDTRONIC INC.
K101271
05/06/2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
MEDTRONIC INC.
K103313
11/10/2010
HEPARIN ASSAY CONTROLS
MEDTRONIC INC.
K103314
11/10/2010
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
MEDTRONIC INC.
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