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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valvulotome
510(k) Number K142660
Device Name Antegrade LeMills Valvulotome
Applicant
LeMaitre Vascular, Inc.
63 Second Ave.
Burlington,  MA  01803
Applicant Contact Xiang (Vic) Zhang
Correspondent
LeMaitre Vascular, Inc.
63 Second Ave.
Burlington,  MA  01803
Correspondent Contact Anna Kasseris
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received09/18/2014
Decision Date 10/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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