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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K022145
Device Name OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
Applicant
LEMAITRE VASCULAR, INC.
26 RAY AVE.
BURLINGTON,  MA  01803
Applicant Contact JAMES ASHBY
Correspondent
LEMAITRE VASCULAR, INC.
26 RAY AVE.
BURLINGTON,  MA  01803
Correspondent Contact JAMES ASHBY
Regulation Number870.5150
Classification Product Code
DXE  
Date Received07/02/2002
Decision Date 01/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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