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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K021899
Device Name CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072
Applicant
Concentric Medical, Inc.
2585 Leghorn St.
Moutian View,  CA  94043
Applicant Contact KEVIN MACDONALD
Correspondent
Concentric Medical, Inc.
2585 Leghorn St.
Moutian View,  CA  94043
Correspondent Contact KEVIN MACDONALD
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/10/2002
Decision Date 07/10/2002
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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