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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 K071367
Device Name FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
Applicant
LeMaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Applicant Contact MINNIE MILDWOFF
Correspondent
LeMaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Correspondent Contact MINNIE MILDWOFF
Regulation Number870.4450
Classification Product Code
MJN  
Date Received05/16/2007
Decision Date 08/29/2007
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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