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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K001621
Device Name DARDIK CAROTID SHUNT
Applicant
Vascutech, Inc.
164 Middlesex Tpke.
Burlington,  MA  01803
Applicant Contact TRENT G KAMKE
Correspondent
Vascutech, Inc.
164 Middlesex Tpke.
Burlington,  MA  01803
Correspondent Contact TRENT G KAMKE
Regulation Number870.4450
Classification Product Code
MJN  
Date Received05/26/2000
Decision Date 12/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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