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FDA 510(k) Applications Submitted by DANNETTE CROOMS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K120780
03/14/2012
EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
EDWARDS LIFESCIENCES, LLC.
K102420
08/25/2010
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
EDWARDS LIFESCIENCES, LLC.
K123298
10/23/2012
FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
EDWARDS LIFESCIENCES, LLC.
K123303
10/23/2012
FEMORAL ACCESS VENOUS CANNULAE
EDWARDS LIFESCIENCES, LLC.
K113411
11/18/2011
EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA
EDWARDS LIFESCIENCES, LLC.
K113459
11/22/2011
ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING
EDWARDS LIFESCIENCES, LLC.
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