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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 K021958
Device Name TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H
Applicant
BACCHUS VASCULAR, INC.
3110 CORONADO DR.
SANTA CLARA,  CA  95054
Applicant Contact GREG MATHINSON
Correspondent
BACCHUS VASCULAR, INC.
3110 CORONADO DR.
SANTA CLARA,  CA  95054
Correspondent Contact GREG MATHINSON
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received06/14/2002
Decision Date 07/03/2002
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
Recalls CDRH Recalls
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