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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name sensor, pressure, aneurysm, implantable
De Novo Number DEN050006
510(K) Number K050939
Device Name CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
Requester
cardiomems inc
75 fifth st., nw
suite 440
atlanta,  GA  30308
Contact carol vierling
Regulation Number870.2855
Classification Product Code
NQH  
Date Received08/09/2005
Decision Date 10/28/2005
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
Type Post-NSE
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