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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 K973669
Device Name THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)
Applicant
Micro Therapeutics, Inc.
1062-F Calle Negocio
San Clemente,  CA  92673
Applicant Contact BRAIN STRAUSS
Correspondent
Micro Therapeutics, Inc.
1062-F Calle Negocio
San Clemente,  CA  92673
Correspondent Contact BRAIN STRAUSS
Regulation Number870.4875
Classification Product Code
MCW  
Date Received09/25/1997
Decision Date 02/06/1998
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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