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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(K) Number K121734
Device Name PLATO MICROCATH 27 MICROCATHETER
Applicant
SCIENTIA VASCULAR , LLC
2700 south 900 west
suite d
salt lake city,  UT  84119
Contact sharon rockwell
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/13/2012
Decision Date 07/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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