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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 K130904
Device Name TRELLIS-8 PERIPHERAL INFUSION SYSTEM
Applicant
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact JENNIFER SULLIVAN
Correspondent
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact JENNIFER SULLIVAN
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received04/01/2013
Decision Date 10/25/2013
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
Recalls CDRH Recalls
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