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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 K071234
Device Name ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
Applicant
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P O Box 7393
Mountain View,  CA  94039
Applicant Contact SHEILA W PICKERING
Correspondent
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P O Box 7393
Mountain View,  CA  94039
Correspondent Contact SHEILA W PICKERING
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received05/03/2007
Decision Date 06/29/2007
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
Recalls CDRH Recalls
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