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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 K022640
Device Name SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
Applicant
Bacchus Vascular, Inc.
3110 Coronado Dr.
Santa Clara,  CA  95054
Applicant Contact GREGORY J MATHISON
Correspondent
Bacchus Vascular, Inc.
3110 Coronado Dr.
Santa Clara,  CA  95054
Correspondent Contact GREGORY J MATHISON
Regulation Number870.4875
Classification Product Code
MCW  
Date Received08/08/2002
Decision Date 12/02/2002
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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