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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name balloon aortic valvuloplasty
510(K) Number K122012
Models 302, 305
Device Name Z-MED Z-MED II
Applicant
NUMED, INC.
2880 main st.
hopkinton,  NY  12965
Contact nichelle laflesh
Regulation Number870.1250
Classification Product Code
OZT  
Date Received07/10/2012
Decision Date 10/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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