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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K071529
Device Name XTRACT CATHETER SYSTEM
Applicant
Lumen Biomedical, Inc.
14505 21st Ave. N.
Suite 212
Plymouth,  MN  55447
Applicant Contact MARIA E BRITTLE
Correspondent
Lumen Biomedical, Inc.
14505 21st Ave. N.
Suite 212
Plymouth,  MN  55447
Correspondent Contact MARIA E BRITTLE
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received06/05/2007
Decision Date 08/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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