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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 K972110
Device Name Cordis Endeavor Infusion Catheter
Applicant
Cordis Corp.
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact ARIEL MACTAVISH
Correspondent
Cordis Corp.
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact ARIEL MACTAVISH
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received06/05/1997
Decision Date 08/14/1997
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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