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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K083370
Device Name D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006
Applicant
Artegraft, Inc.
220 N. Center Dr.
North Brunswick,  NJ  08902
Applicant Contact LAURENCE A POTTER
Correspondent
Artegraft, Inc.
220 N. Center Dr.
North Brunswick,  NJ  08902
Correspondent Contact LAURENCE A POTTER
Regulation Number870.5150
Classification Product Code
QEW  
Date Received11/14/2008
Decision Date 12/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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