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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 K103356
Device Name PRUITT CAROTID KIT
Applicant
LeMaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Applicant Contact VIC ZHANG
Correspondent
LeMaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Correspondent Contact VIC ZHANG
Regulation Number870.4450
Classification Product Code
MJN  
Subsequent Product Code
FTM  
Date Received11/16/2010
Decision Date 12/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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