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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K963925
Device Name THROMBOLYTIC BRUSH CATHETER
Applicant
Micro Therapeutics, Inc.
1062-F Calle Negocio
San Clemente,  CA  92673
Applicant Contact LINDA D'ABATE
Correspondent
Micro Therapeutics, Inc.
1062-F Calle Negocio
San Clemente,  CA  92673
Correspondent Contact LINDA D'ABATE
Regulation Number870.4875
Classification Product Code
MCW  
Date Received09/30/1996
Decision Date 08/08/1997
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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