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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K033997
Device Name SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
Applicant
Bacchus Vascular, Inc.
3110 Coronado Dr.
Santa Clara,  CA  95054
Applicant Contact LISA CAPARRA
Correspondent
Bacchus Vascular, Inc.
3110 Coronado Dr.
Santa Clara,  CA  95054
Correspondent Contact LISA CAPARRA
Regulation Number870.4875
Classification Product Code
MCW  
Date Received12/24/2003
Decision Date 02/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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