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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 K023514
Device Name TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH)
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 Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received10/21/2002
Decision Date 12/02/2002
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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