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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K132474
Device Name CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
Applicant
Acist Medical Systems
7905 Fuller Rd.
Eden Prairie,  MN  55344
Applicant Contact MATTHEW STEPANEK
Correspondent
Acist Medical Systems
7905 Fuller Rd.
Eden Prairie,  MN  55344
Correspondent Contact MATTHEW STEPANEK
Regulation Number870.2870
Classification Product Code
DXO  
Subsequent Product Code
OBI  
Date Received08/07/2013
Decision Date 01/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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