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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oxygenator, cardiopulmonary bypass
510(K) Number K120185
Device Name INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
Applicant
SORIN GROUP ITALIA S.R.L.
195 west street
waltham,  MA  02451
Contact barry sall
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received02/06/2012
Decision Date 05/11/2012
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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