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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K033650
Device Name ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
Applicant
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
Mountain View,  CA  94039 -7393
Applicant Contact ISKRA MRAKOVIC
Correspondent
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
Mountain View,  CA  94039 -7393
Correspondent Contact ISKRA MRAKOVIC
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Code
ITX  
Date Received11/20/2003
Decision Date 02/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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