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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mechanical thrombolysis catheter
510(k) Number K071664
Device Name TRELLIS-6 PERIPHERAL INFUSION SYSTEM
Applicant
BACCHUS VASCULAR, INC.
3110 CORONADO DR.
SANTA CLARA,  CA  95054
Applicant Contact ANTHONY SOWUNMI
Correspondent
BACCHUS VASCULAR, INC.
3110 CORONADO DR.
SANTA CLARA,  CA  95054
Correspondent Contact ANTHONY SOWUNMI
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received06/18/2007
Decision Date 07/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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