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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 balloon aortic valvuloplasty
De Novo Number DEN080015
510(K) Number K082776
Device Name NUCLEUS-X PTV CATHETER
Requester
numed, inc.
2880 main st.
hopkinton,  NY  12965
Contact nichelle laflesh
Regulation Number870.1255
Classification Product Code
OZT  
Date Received12/24/2008
Decision Date 06/11/2012
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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