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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 K013635
Device Name TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)
Applicant
BACCHUS VASCULAR, INC.
3110 CORONADO DR.
SANTA CLARA,  CA  95054
Applicant Contact GREG MATHISON
Correspondent
BACCHUS VASCULAR, INC.
3110 CORONADO DR.
SANTA CLARA,  CA  95054
Correspondent Contact GREG MATHISON
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received11/05/2001
Decision Date 02/11/2002
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
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